MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-02-08 for UNKNOWN ZIMMER HOLMAN RETRACTOR manufactured by Zimmer, Inc..
[19948076]
Info was received from medwatch form (b)(4). Eval summary: at the time of this report, no device or photos were returned for eval. The history of this particular holman retractor is not known. As a result the age, number of uses, abuse, care, etc. Are not known. With the info provided no root cause for the reported breakage of the holman retractor can be determined. Review of the device history records was not possible as the product and/or lot numbers required for retrieval were unavailable. It is not suspected that the product failed to meet specifications. The investigation could not verify or identify any evidence of product contribution to the reported problem. Based on the available info, the need for corrective action is not indicated. Should additional substantive info be received, the complaint will be reopened. Zimmer, inc. Considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
[20089150]
It is reported that the tip of the instrument broke off during a hip resurfacing procedure. Surgeon and resident continued on with the surgery and the tip was later removed from the pt prior to closing the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2011-00194 |
| MDR Report Key | 2064542 |
| Report Source | 00 |
| Date Received | 2011-02-08 |
| Date of Report | 2011-01-10 |
| Date of Event | 2010-10-12 |
| Date Mfgr Received | 2011-01-10 |
| Date Added to Maude | 2011-04-26 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ZIMMER HOLMAN RETRACTOR |
| Generic Name | HIP INSTRUMENT |
| Product Code | HXO |
| Date Received | 2011-02-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-08 |