PINNACLE 2218-87-354Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295101925), received between Nov 7, 2017 and Mar 14, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (5 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE TEST INSERT WAS BROKEN. THE SPECIALIST WAS ANNOYED THAT THERE WERE NO MORE TEST INSERTS OF THE SAME CHARACTERISTICS AND MEASUREMENTS INSIDE THE EQUIPMENT. THERE WAS NO WAY TO GIVE A SOLUTION, AND THEN IT WAS RESOLVED USING THIS SAME TEST IMPLANT WITHOUT THE PART OF THE SCREW THAT WAS BROKEN, AND HAD TO REMOVE IT WITH A KELLY CLIP. THE SURGERY WAS SUCCESSFULLY COMPLETED, BUT WITH AN AFFECTATION OF (15) FIFTEEN MINUTES IN THE SURGICAL TIMES BY THE MANEUVER THAT HAD TO BE PERFORMED WITH THE CLAMP. THERE WERE NO AFFECTATIONS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607626 ↗
• MalfunctionFeb 18, 2022Naturally Worn; Naturally Worn

  THE HOSPITAL HAVE REPORTED THAT THE ITEMS NEED TO BE REPLACED, WEAR & TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560850 ↗
• MalfunctionOct 16, 2020Scratched Material; Scratched Material

  CSSD MANAGER IDENTIFIED DEEP GOUGES AND SCRATCHES ON PINNACLE LINER TRIALS, AND CONCERNED ABOUT DEBRIS BUILD UP RESULTING IN DESTERILIZATION. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(6). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(6). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.: TRUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690651 ↗
• MalfunctionJul 24, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  STAFF HAVE INDICATED THAT THE MENTIONED LINER TRIALS HAVE ALL BEEN STRIPPED AND NO LONGER PROPERLY WORK WITH THE SCREWDRIVER FOR INSERTION OR REMOVAL. THE LINER IMPACTOR HANDLE HAS BEEN CRACKED DUE TO WEAR AND TEAR AND ALSO NEEDS REPLACING. PLEASE SEND REPLACEMENTS AS SOON AS POSSIBLE. DID NOT OCCUR INTRA-OP AND THEREFORE NO PATIENT ISSUES OR SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENTS DIRECT TO THE FOLLOWING ADDRESS: (B)(6). PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323246 ↗
• MalfunctionNov 5, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037751 ↗
• MalfunctionNov 5, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037723 ↗
• MalfunctionNov 5, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037710 ↗
• MalfunctionNov 5, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037666 ↗
• MalfunctionNov 7, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STERILE SERVICES IDENTIFIED THAT THE INSTRUMENT WAS DAMAGED. THERE IS NO INFORMATION ABOUT HOW IT HAPPENED. THE SET HAS BEEN QUARANTINED.

  Patient problems: No Information

  MAUDE report 7007583 ↗