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 2018-05-14 for SHAFT F/AWL F/04.630.135S 03.630.144 manufactured by Oberdorf Synthes Produktions Gmbh.
[108227469]
Patient information was not provided for reporting. Device is an instrument and is not implanted / explanted. Device is expected to be returned for manufacturer review/investigation, but has not been received yet. Reporter facility contact number was not provided. Device is not distributed in the united states, but is similar to device marketed in the usa. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review could not be completed without lot number. Device was used for treatment, not diagnosis. 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
[108227470]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during the surgery, it was noted that the handle for the awl that prepares the bone bed for screw insertion was missing from the loan tray. The surgeon subsequently tried to use it without the handle but the tip of the shaft snapped off in patient. This could not be retrieved and was left in the patient. Surgery and patient outcome were not reported. This report is for one (1) shaft f/awl f/04. 630. 135s. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-53750 |
| MDR Report Key | 7512379 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-14 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-04-18 |
| Date Mfgr Received | 2018-06-21 |
| Device Manufacturer Date | 2015-07-02 |
| Date Added to Maude | 2018-05-14 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES SELZACH |
| Manufacturer Street | BOHACKERWEG 5 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHAFT F/AWL F/04.630.135S |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2018-05-14 |
| Returned To Mfg | 2018-06-05 |
| Catalog Number | 03.630.144 |
| Lot Number | 1502741 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-14 |