MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-11-11 for PEDICAWL ?3 L230 F/SCR ?4+4.2 388.551 manufactured by Synthes Usa.
[59842916]
This device was used for treatment, not diagnosis. (b)(4). Device is an instrument and is not implanted/explanted. (b)(6). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[59842917]
Device report from synthes (b)(6) reports an event as follows: it was reported that during an unknown surgery it was detected that the wooden handled instrument of a set appeared to have tiny wooden splinters shearing away while it was being used for hammering. The hospital checked the other two (2) sets and wear and tear were noted in all three (3) kits. After troubleshooting they were able to replace the screw without the surgery being prolonged. No information about patient condition received. Concomitant reported part: 1x screw (part and lot number unknown). This report is 2 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2016-15343 |
| MDR Report Key | 6095032 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-11 |
| Date of Report | 2016-10-20 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2016-10-20 |
| Date Added to Maude | 2016-11-11 |
| 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 | MARK VORNHEDER |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEDICAWL ?3 L230 F/SCR ?4+4.2 |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2016-11-11 |
| Catalog Number | 388.551 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 2016-11-11 |