MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-12-06 for GRAY REVISION CEMENT FORCEPS 6210-9-080 manufactured by Howmedica Inc..
[37034]
The tip of the forceps "broke off" during surgery. There was no adverse consequence to any pt or delay in surgical or anesthesia time.
Patient Sequence No: 1, Text Type: D, B5
[18380317]
The root cause of this event is attributed to misuse of the device by the user. The device is intended to remove pre-loosened cement particles from the femur. The device is not intended to break cement from the cement mantle. Corrective action has been implemented to prevent misuse and the likelihood of failure if misused.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2219689-1996-00294 |
| MDR Report Key | 54696 |
| Report Source | 07 |
| Date Received | 1996-12-06 |
| Date of Report | 1996-12-05 |
| Date of Event | 1996-10-23 |
| Date Facility Aware | 1996-10-23 |
| Report Date | 1996-12-05 |
| Date Mfgr Received | 1996-11-05 |
| Date Added to Maude | 1996-12-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAY REVISION CEMENT FORCEPS |
| Generic Name | INSTRUMENT |
| Product Code | LZV |
| Date Received | 1996-12-06 |
| Returned To Mfg | 1996-01-19 |
| Model Number | NA |
| Catalog Number | 6210-9-080 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 55249 |
| Manufacturer | HOWMEDICA INC. |
| Manufacturer Address | 359 VETERANS BLVD. RUTHERFORD NJ 07070 US |
| Baseline Brand Name | GRAY REVISION CEMENT FORCEPS |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 6210-9-080 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-06 |