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 OFFSET DOUBLE CLAMP BAR 00-1238-004-00 manufactured by Zimmer Orthopaedic Surgical Products.
[1137317]
A 31" offset double clamp bar was returned to the mfr. Visual inspection revealed a broken clamp. There was no report of injury or medical intervention associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
[8475764]
Visual inspection of the returned device confirmed that the clamp was broken. This mdr is being submitted late, as it was identified as part of a retrospective review conducted by zimmer orthopedic surgical products (zimmer osp). This retrospective review was conducted in response to an inspectional observation at a zimmer facility. The agency's inspectional observation concerned the company's decision(s) not to submit certain mdrs for products specific to that zimmer facility. While a retrospective review of complaints for unreported mdrs was conducted immediately following the inspection at the facility, zimmer determined that such a review would be conducted at all zimmer facilities. As a result, zimmer osp completed its retrospective review and is now submitting this mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1035617-2009-00029 |
| MDR Report Key | 1475801 |
| Report Source | 05,07 |
| Date Received | 2009-06-12 |
| Date of Report | 2007-08-08 |
| Date of Event | 2007-08-01 |
| Date Mfgr Received | 2007-02-01 |
| Date Added to Maude | 2010-03-19 |
| 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 W. OHIO AVE. |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| 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 | OFFSET DOUBLE CLAMP BAR |
| Generic Name | OFFSET DOUBLE CLAMP BAR |
| Product Code | ILZ |
| Date Received | 2009-06-12 |
| Returned To Mfg | 2007-08-28 |
| Model Number | NA |
| Catalog Number | 00-1238-004-00 |
| 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 |