FDA Adverse Event
Malfunction
Summary report: N
ELITE PASS SHUTTLE NEEDLE, BOX OF 5
MDR report key: 1070804
·
Received July 3, 2008
Report
- Report Number
- 1219602-2008-00158
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 4, 2008
- Report Date
- June 4, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIVISION
- Product Code
- HXI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF THE NEEDLE SHOWS IT BROKE AT THE SUTURE PICK-UP SLOT. NO CONCLUSION COULD BE MADE FOR THE DEVICE FAILURE.
Description of Event or Problem · 1
DURING A SHOULDER REPAIR PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT. THE NEEDLE WAS PASSED 1 OR 2 TIMES AND THEN IT WAS NOTED THAT THE TIP HAD BROKEN FREE. IT TOOK ABOUT AN HOUR TO TRY AND LOCATE THE PIECE FOR REMOVAL, BUT WAS UNSUCCESSFUL. A BACK-UP NEEDLE WAS SUCCESSFULLY USED TO COMPLETE THE REPAIR. FOLLOW-UP VISIT, X-RAY SHOWED THAT THE BROKEN PIECE DID NOT MOVE. AT THIS TIME, THERE ARE NO PLANS FOR ADDITIONAL SURGERY TO REMOVE THE PIECE FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELITE PASS SHUTTLE NEEDLE, BOX OF 5 | ELITE PASS | HXI | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 7210693 | 50249531 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |