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 2020-03-27 for INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM 03.010.472 manufactured by Oberdorf Synthes Produktions Gmbh.
[186527064]
Product complaint # (b)(4). Device returned. Reporter is a synthes rep. A review of the device history record has been requested. The device was received, the investigation is in progress, the investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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
[186527065]
Device report from synthes reports an event in (b)(6) as follows: it was reported that the locking mechanism distal of the screwdriver broke. The screwdriver bended while using, it couldn? T handle the force used. The issue was discovered during a surgical procedure, no impact to the patient, a different screwdriver was used to complete the procedure. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02321 |
| MDR Report Key | 9889094 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-02-14 |
| Date Added to Maude | 2020-03-27 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK H |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM |
| Generic Name | SCREWDRIVERS |
| Product Code | HXX |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-09 |
| Catalog Number | 03.010.472 |
| Lot Number | 1L98992 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-27 |