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 2020-03-30 for 4.3MM THREADED LCP(TM) DRILL GUIDE 323.042 manufactured by Oberdorf Synthes Produktions Gmbh.
[186734826]
The visual inspection of the lcp drill sleeve has shown that a part of the distal threaded tip broken off. The broken off fragment was not returned for investigation. Besides, the instrument presents normal signs of use. The relevant feature is deformed in a manner which prevents accurate measurement of the feature. A functional test can not be performed of the detected damage. The complaint condition is confirmed as a part of the distal threaded tip broken off. This production lot (9128118) was manufactured in september 2014 according to the specification. The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported. The correct material was used, and the hardness parameters were within the specifications. There were no issues during the manufacture of this product that would contribute to this complaint condition. The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device. While no definitive root cause could be determined, it is possible that the device encountered excessive torque/force and/or cross threading with mating plates during device use. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Device history lot part: 323. 042 lot: 9128118 manufacturing site: (b)(4). Release to warehouse date: 23 september 2014 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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
[186734827]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent open reduction internal fixation surgery for tibial plateau fracture with the lcp drill sleeve in question. When the surgeon used the drill sleeve, the surgeon found that the drill sleeve had been broken. The surgeon did not know when the drill sleeve was broken intra-operation or pre-operation. It was not reported how the surgery was completed. The surgical delay is unknown. No further information is available. This report is for one (1) 4. 3mm threaded lcp(tm) drill guide this is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02405 |
| MDR Report Key | 9898102 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-30 |
| 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 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| 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 | 4.3MM THREADED LCP(TM) DRILL GUIDE |
| Generic Name | GUIDE, SURGICAL, INSTRUMENT |
| Product Code | FZX |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-16 |
| Catalog Number | 323.042 |
| Lot Number | 9128118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-30 |