T2 1897-6110SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540384829), received between Aug 13, 2018 and Apr 8, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CAME IN WITH PAIN AND THE NAIL WAS BROKEN AT THE BOTTOM JUNCTURE OF LOWER RECON SCREW. THE SURGEON REMOVED THE T2 ALPHA RETROGRADE NAIL AND REPLACED IT WITH A GAMMA NAIL. SURGERY WAS SUCCESSFUL.

  Patient problems: Implant Pain

  MAUDE report 14059431 ↗
• InjuryJul 1, 2020Malposition of Device; Malposition of Device

  THE CUSTOMER REPORTED: "ABSENCE OF LOCKING OF THE CERVICOCEPHALIC SCREWS IN THE NAIL". UPDATE 08/06/2020. SALES REP REPORTED: "SO I MET THE SURGEON TODAY. THIS IS A T2 RECON NAIL AND 2019 AND 2 CERVICAL SCREWS PLACED ON AUGUST 28. THE INTERVENTION WENT WELL WITHOUT ANY DELAY IN THE INSTALLATION OF THE MATERIAL. DURING THE POST-OP CONTROL THE NAIL LOOKS WELL PLACED. ON THE OTHER HAND, THE SURGEON NOTICED ON THE CONTROL X-RAYS AT 3 MONTHS THAT THE CERVICAL SCREWS WERE NOT INSERTED INSIDE THE NAIL BUT OUTSIDE IT. HE DID A MATERIAL VIGILANCE ON THE FACT THAT THE TARGET DEVICE HAD AIMED NEXT TO IT AND ISOLATED THE IMPLANTS (1 NAIL, 2 CERVICAL SCREWS). HE TOOK THE PATIENT BACK ON (B)(6) 2019 WITH A LONG GAMMA 3 NAIL AND THE PATIENT IS NOW SOLID." UPDATE 09/06/2020. ACCORDING TO THE SALES MANAGER "THE SCREWS WERE NEVER INSIDE THE NAIL, THIS IS A MISTAKE OF AIMING AND A BAD RADIOGRAPHIC CONTROL DURING THE INTRAOPERATIVE PERIOD."

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10218221 ↗
• MalfunctionFeb 3, 2020Fracture; Difficult to Insert; Fracture; Difficult to Insert

  IT WAS REPORTED, WHEN THE LAG SCREW WAS INSERTED, IT INTERFERED WITH THE SCREW HOLE OF THE NAIL AND THE SCREW TIP WAS DAMAGED. THE BROKEN TIP WAS LEFT INSIDE THE PATIENT. THE PATIENT WAS YOUNG AND HIS BONE QUALITY WAS GOOD, SO THE DIRECTION WAS SLIGHTLY DEVIATED AND COULD NOT BE CORRECTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9659636 ↗
• InjuryAug 13, 2018Break

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(6) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿T2 RECON IN THE (B)(6) HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 2009 AND 2017. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 13 EVENTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO SEQUENCE AFTER HIP FRACTURE.

  Patient problems: Hip Fracture

  MAUDE report 7779106 ↗
• InjuryAug 13, 2018Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(6) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿T2 RECON IN THE (B)(6) HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 2009 AND 2017. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 13 EVENTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO DEEP INFECTION. THE PATIENT RECEIVED A DRAINAGE. IT WAS ALSO INDICATED THAT PATIENT PASSED AWAY WITHIN 60 DAYS SINCE THE REVISION SURGERY HOWEVER THE CAUSE AND THE DATE OF THE DEATH WILL NOT BE DISCLOSED.

  Patient problems: Death; Unspecified Infection

  MAUDE report 7777585 ↗