T-FIX RCG STERILE PAC
Report
- Report Number
- 1219602-2024-01292
- Event Type
- Malfunction
- Date Received
- June 14, 2024
- Date of Event
- February 20, 2024
- Report Date
- June 14, 2024
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HRX
- UDI-DI
- 03596010446114
- PMA / PMN Number
- K925573
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT IT IS NOT IN ITS ORIGINAL PACKAGING. THE DRILL IS FRACTURED INTO SEVERAL PIECES. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE HAS BEEN ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE AN IMPACT EVENT TO THE DEVICE INCONSISTENT WITH NORMAL USE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LATARJET SURGERY, WHEN DRILLING A BONE HOLE BY THE GLENOID FOSSA, THE PART OF THE T-FIX THAT CONNECTS TO THE OUTER DRILL CAME OFF AND THE DEVICE COULD NO LONGER BE CONNECTED TO THE OUTER DRILL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 10 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 864676 | T-FIX RCG STERILE PAC | ARTHROSCOPE | HRX | SMITH & NEPHEW, INC. | 2125978 | 03596010446114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |