MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-06-12 for SWIVEL CLAMP BAR 00-1042-003-00 manufactured by Zimmer Orthopaedic Surgical Products.
[1257608]
A customer reported nine incidents of broken clamps on the 48" swivel clamp bar. There was no report of pt injury or medical intervention associated with these incidents.
Patient Sequence No: 1, Text Type: D, B5
[8474772]
Visual inspection of the returned devices confirmed that the clamps were broken. This medwatch is being submitted late, as it was identified during a retrospective review conducted pursuant to a fda inspection at the mfr's facility in jan, 2008, and in response to an inspectional observation. The agency's inspectional observation concerned the mfr's decision not to submit mdrs for certain events involving product manufactured at the facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1035617-2009-00012 |
| MDR Report Key | 1475792 |
| Report Source | 05,07 |
| Date Received | 2009-06-12 |
| Date of Report | 2006-04-10 |
| Date of Event | 2006-04-01 |
| Date Mfgr Received | 2009-04-10 |
| Date Added to Maude | 2009-10-26 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN WATKINS |
| Manufacturer Street | 200 WEST OHIO AVE. |
| Manufacturer City | DOVER OH 44266 |
| Manufacturer Country | US |
| Manufacturer Postal | 44266 |
| Manufacturer Phone | 3303649483 |
| Manufacturer G1 | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Street | 2021 OLD MOUNTAIN RD. |
| Manufacturer City | STATESVILLE NC 28677 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28677 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWIVEL CLAMP BAR |
| Generic Name | SWIVEL CLAMP BAR |
| Product Code | ILZ |
| Date Received | 2009-06-12 |
| Returned To Mfg | 2006-04-20 |
| Model Number | NA |
| Catalog Number | 00-1042-003-00 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Address | 2021 OLD MOUNTAIN RD. STATESVILLE NC 28677 US 28677 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-12 |