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 00-1042-090-00 manufactured by Zimmer Orthopaedic Surgical Products.
[1136793]
A customer reported four incidents of broken clamps on the 31" offset double clamp bar. There was no report of pt injury or medical intervention associated with these incidents.
Patient Sequence No: 1, Text Type: D, B5
[8311756]
One 31" offset double clamp bar was returned for evaluation. Visual inspection revealed that one clamp was broken at the location of the hinge. The second clamp at the opposite end of the bar was determined to be broken at the location of the base. 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 | 1035617-2009-00013 |
| MDR Report Key | 1475791 |
| Report Source | 05,07 |
| Date Received | 2009-06-12 |
| Date of Report | 2006-04-21 |
| Date of Event | 2006-04-01 |
| Date Mfgr Received | 2006-04-21 |
| Date Added to Maude | 2010-02-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 | 2006-04-28 |
| Model Number | NA |
| Catalog Number | 00-1042-090-00 |
| 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 |