MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-17 for UNKNOWN MCP INSTRUMENT UNK_SEL manufactured by Stryker Gmbh.
[120829192]
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[120829193]
Customer reported that during surgery, the mcp instrument was available for use instead of the pip instrument. The surgeon only realized with the patient asleep on the table and with the hand opened. The surgeon then proceeded to try his best to implant 2 x pip implants however this was unsuccessful and the patient will need relisted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2018-00605 |
| MDR Report Key | 7883136 |
| Date Received | 2018-09-17 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-08-20 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-09-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN MCP INSTRUMENT |
| Generic Name | IMPLANT |
| Product Code | KYJ |
| Date Received | 2018-09-17 |
| Catalog Number | UNK_SEL |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-17 |