FDA Adverse Event
Malfunction
Summary report: N
CABLE-READY CABLE GRIP SYSTEM CABLE PIN SYSTEM CRIMPER ASSEMBLY
MDR report key: 1030253
·
Received April 15, 2008
Report
- Report Number
- 1822565-2008-00174
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- March 12, 2008
- Report Date
- March 13, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: THE RETURNED CRIMPER ASSEMBLY INSTRUMENT WAS TESTED FUNCTIONALLY AND IT DID HOLD THE TENSION AS INTENDED. THERE WERE NO MFG OR DESIGN DISCREPANCIES FOUND. CAUSE CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THERE IS NO INDICATION THAT DESIGN OR MFR CONTRIBUTED TO THIS OUTCOME. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.
Description of Event or Problem · 1
IT IS REPORTED THAT THE CRIMPER TENSIONER DID NOT HOLD TENSION DURING SURGERY USING CABLE SUTURE TO CLOSE STERNUM FOR HEART SURGERY. THE SURGERY TIME WAS PROLONGED BY 45 MINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CABLE-READY CABLE GRIP SYSTEM CABLE PIN SYSTEM CRIMPER ASSEMBLY | CRIMPER ASSEMBLY | LXH | ZIMMER, INC. | NA | 52073200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |