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 2020-03-13 for 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES 03.114.001 manufactured by Oberdorf Synthes Produktions Gmbh.
[188258762]
Device used in a veterinary case - no patient information will be reported. Complainant part is not expected to be returned for manufacturer review/investigation. Part # 03. 114. 001, synthes lot # h363239, supplier lot # h363239, release to warehouse date: 15 nov 2017, supplier: (b)(6), no ncr's were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[188258783]
Device report from (b)(6) reports an event as follows: it was reported that on an unknown date during an unknown surgery, the surgeon could not attach the drill sleeve to a plate properly. When the drill sleeve was attached to the plate, it quickly came off. It seemed that the drill sleeve could not be inserted into a plate hole deeply. The surgery was completed with less than a thirty (30) minute delay. This report is for one 1. 1mm lcp threaded drill guide for 1. 5mm lcp plates. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-01889 |
| MDR Report Key | 9828884 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2017-11-15 |
| Date Added to Maude | 2020-03-13 |
| 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 | 1302 WRIGHT 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 | 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES |
| Generic Name | GUIDE |
| Product Code | FZX |
| Date Received | 2020-03-13 |
| Catalog Number | 03.114.001 |
| Lot Number | H363239 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-13 |