MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-15 for 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES 03.114.001 manufactured by Oberdorf Synthes Produktions Gmbh.
[102878658]
Device used in a veterinary case - no patient information will be reported. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. A device history record (dhr) review was performed for: part number: 03. 114. 001 , synthes lot number: h288454 , supplier lot number: (b)(4). Release to warehouse date: 27-feb-2017 , supplier: (b)(4), manufacturing site: (b)(4). No ncrs 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 subcomponents, which would contribute to this complaint condition. 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
[102878659]
Device report from synthes on an event in (b)(6) as follows: this report is for a veterinary case. There was no human patient involvement. It was reported, that the drill sleeve doesn't fix the plates and screws, therefore, they don't assembly properly. This complaint involves 1 part. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-52099 |
| MDR Report Key | 7342106 |
| Date Received | 2018-03-15 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-02-13 |
| Date Mfgr Received | 2019-02-11 |
| Device Manufacturer Date | 2017-02-27 |
| Date Added to Maude | 2018-03-15 |
| 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 | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA |
| Manufacturer Country | SZ |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0669-2018 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES |
| Generic Name | GUIDE |
| Product Code | FXZ |
| Date Received | 2018-03-15 |
| Returned To Mfg | 2019-01-08 |
| Catalog Number | 03.114.001 |
| Lot Number | H288454 |
| 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 | 2018-03-15 |