EXPert Nail 04.034.452SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982095251), received between Nov 22, 2017 and Aug 23, 2021 — classified as 7 injuries.

2 other recalls cover devices cleared under the same FDA submission (K040762); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY. DURING THE SURGERY, ALL DEVICES WERE INTACT, NO ITEMS WERE BROKEN, AND WERE REMOVED SUCCESSFULLY AND WITHOUT DIFFICULTY. ORIGINALLY, THE PATIENT UNDERWENT FOR REMOVAL HARDWARE OF A LEFT TIBIAL SHAFT FRACTURE FOR INFECTION ON (B)(6) 2020. THE CURRENT REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT WAS FIN POSTOPERATIVELY. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE. THIS REPORT IS 6 OF 13 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12356633 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A PROCEDURE DUE TO AN INFECTION OF A LEFT TIBIAL FRACTURE. INITIALLY, THE ORIGINAL DATE OF THE SURGERY WAS ON (B)(6) 2021. POST OP EVALUATION WAS AN INFECTION, DECISION WAS MADE TO REMOVED HARDWARE. ALL ITEMS WERE INTACT THERE WERE NO FRAGMENTS, NO BROKEN PIECES. PATIENT HAS TURN SURGERY WELL AND WAS DOING FINE POSTOPERATIVELY. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE. THIS REPORT IS 4 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12316212 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF TITANIUM CANNULATED TIBIAL NAILS- EX WITH PROXIMAL BEND DUE TO NON-UNION ON (B)(6) 2020. THE PATIENT HAD AN ORIGINAL IMPLANT ON (B)(6) 2020. THE TITANIUM CANNULATED TIBIAL NAILS WAS REMOVED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 10MM TITANIUM (TI) CANNULATED TIBIAL NAIL. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 10413917 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL REVISION SURGERY WAS PERFORMED DUE TO TIBIA DELAYED UNION. THE DATE OF THE ORIGINAL IMPLANTATION WAS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO KNOWN SURGICAL DELAY THIS IS REPORT 2 OF 6 (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 10390543 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT DEVELOPED AN INFECTION. ORIGINALLY, SIX (6) MONTHS AGO, THE PATIENT HAD AN IMPLANTATION WITH A CANNULATED TIBIA NAIL AS WELL AS THE RIGHT DISTAL UNKNOWN TIBIAL LOBE LATERAL LOCKING PLATE WITH THE PROXIMAL UNKNOWN LOCKING SCREWS IN THE RIGHT SIDE AND THE TIBIAL NAIL AT THE INSERTION SITE. BOTH PROXIMAL MEDIAL TO LATERAL LOCKING SCREWS IN NAIL WERE IN CLOSE PROXIMITY TO THE INFECTION. INFECTION/INFLAMMATION WAS VISUALLY OBVIOUS. NAIL AND ALL LOCKING SCREWS REMOVED WITHOUT AN INCIDENT. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 10 MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360 MM-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9318810 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS TREATED FOR A GRADE 2 OPEN TIBIA COMMINUTED DIAPHYSEAL SHAFT FRACTURE AND WAS IMPLANTED WITH A 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE UTILIZING THREE (3) UNKNOWN 5MM LOCKING SCREWS ON (B)(6) 2018. DELAYED HEALING AND NONUNION WAS NOTED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY ON (B)(6) 2018 FOR REMOVAL OF TIBIAL NAIL AND INCISION AND DRAINAGE (I&D). THERE WAS NO SURGICAL DELAY AND NO OTHER MEDICAL INTERVENTION WAS NEEDED. THE PATIENT PRESENTLY HAS AN INFECTION. PATIENT STATUS WAS REPORTED AS STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER ADDITIONAL INFORMATION AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Not Applicable; Unspecified Infection

  MAUDE report 7448989 ↗
• InjuryNov 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A MOTOR VEHICLE ACCIDENT ON AN UNKNOWN DATE AND SUBSEQUENTLY SUFFERED A FRACTURED TIBIA AND FIBULA. HE WAS IMPLANTED WITH A TIBIAL NAIL AND LOCKING DISTAL FIBULA PLATE IN (B)(6) 2016. PATIENT NOW PRESENTS WITH AN INFECTED NONUNION. A REVISION SURGERY OCCURRED ON (B)(6) 2017. ONE (1) FIBULA PLATE, THREE (3) UNKNOWN 5 MM LOCKING SCREWS, FOUR (4) UNKNOWN 2.7 MM VARIABLE ANGLE LOCKING SCREWS AND THREE (3) UNKNOWN 2.7 MM CORTEX SCREWS ON FIBULA WERE REMOVED/EXPLANTED AND THE TIBIAL NAIL WAS EXTRACTED. AN OSTEOTOMY WAS DONE ON THE TIBIA AND FIBULA. AN ANTIBIOTIC CEMENT COATED NAIL WAS INSERTED IN PATIENT FOR INFECTION. THERE WAS NO SURGICAL DELAY, HOWEVER, THE SURGEON HAD TO TREPHINE AN UNKNOWN BROKEN SCREW AS IT WAS DIFFICULT TO REMOVE. AN ADDITIONAL X-RAY WAS REQUIRED TO REMOVE THE BROKEN SCREW. THIS SCREW WAS IN THE PROXIMAL PORTION OF NAIL AND WAS BROKEN PRIOR TO SURGERY. ALL SCREW FRAGMENTS WERE REMOVED. THE REMAINDER OF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME REPORTED AS OKAY. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7053380 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040762. One submission often covers many models, so check the product and lot details in each record.

• Z-2051-2015 · Jun 3, 2015 · Terminated
  TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.