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 2017-10-12 for SCRDRIVER ANGL 03.630.026 manufactured by Synthes Hagendorf.
[89290473]
Patient information is unknown. Event date unknown. (b)(4). Implant and explant date is not applicable. Complainant part is not expected to be returned for manufacturer review/investigation. Last name, telephone number and address unknown. Device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number the device history records review could not be completed. The manufacture date is unknown. The investigation could not be completed; no conclusion could be drawn, as no product was received. The investigation could not be completed; no conclusion could be drawn, as no product was received. The teknon inspace has not finally been implanted because the screwdriver mechanism was in poor condition and it broke. The device may have caused or contributed to a serious injury. 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
[89290474]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the teknon inspace has not finally been implanted because the screwdriver mechanism was in poor condition and it broke. In the package only was 1 unit instead of 2 and it was not possible to implant the inspace with the patient already in the operating table and with the approach taken. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003875359-2017-10501 |
| MDR Report Key | 6945549 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-12 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-09-23 |
| Date Mfgr Received | 2017-11-29 |
| Date Added to Maude | 2017-10-12 |
| 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 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES HAGENDORF |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAGENDORF CH4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCRDRIVER ANGL |
| Generic Name | SCREWDRIVER, SURGICAL |
| Product Code | LRZ |
| Date Received | 2017-10-12 |
| Catalog Number | 03.630.026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES HAGENDORF |
| Manufacturer Address | IM BIFANG 6 HAGENDORF CH4614 SZ CH4614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-12 |