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 2019-04-25 for WIRE CUTTER 220MM 391.930 manufactured by Oberdorf Synthes Produktions Gmbh.
[143701292]
The device was not delivered in the original packaging, it was delivered in one sealable bag with the wires probably used in the surgery. The device appears to be in good condition, the blades are good and undamaged. One of the laser weld dots (protection point) is broken. A cutting test with kirschner wire 2,0mm was performed. If the pliers are compressed slowly then the wire is not completely cut through. The cause is in the broken laser weld dot, as result the screw and the screw connection has been loosened, so that the cut of the forceps is insufficient and does not produce enough cutting pressure to cut through the wire. With a fast and strong pressure, the wire is cut off even with a broken laser weld dot. Additional investigation (optional): review of device history record: review of the dhr shows no issues during the manufacturing of the product that would contribute to any malfunction of the product. A review of inspection records showed that the device features have been inspected and were within the specification. In the final inspection was performed a cut sample at 3 places of the cutting edge. The laser dots have been visually inspected in the final inspection according to work instruction and found to be conforming. To investigate the cause of the broken laser welding point, the device was disassembled. No signs of wear or possible malfunctions such as jamming of components have been detected. Summary: the manufacturing evaluation conducted shows that there was no issue during the manufacture of the product that would contribute to this complaint condition. The exact cause for broken laser weld dot cannot be exactly determined however it is most likely that the laser dot was broken by excessive load on the screw by use of the device. No manufacturing issue was found during investigation, therefore no prm documents were reviewed. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Device history lot part number: 391. 930, synthes lot number: t993403, release to warehouse date: 07/23/2013 , manufacture site: synthes (b)(4), part expiration date: n/a. A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition. No ncrs were generated during the production of this device. Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. 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
[143701293]
Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent an open reduction internal fixation (orif) surgery on (b)(6) 2019. When the surgeon tried to cut an unknown 1. 8mm k-wire with a wire cutter, the wire could not be cut. The wire cutter was a new, and had been purchased at the end of (b)(6) 2019. The surgery was completed successfully with no delay. There was no adverse consequence to the patient. Concomitant device: unknown k-wire (part# unknown, lot# unknown, quantity# 1). This report is for one (1) wire cutter 220mm. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-63144 |
| MDR Report Key | 8550934 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-02-08 |
| Date Mfgr Received | 2019-04-01 |
| Device Manufacturer Date | 2013-07-23 |
| Date Added to Maude | 2019-04-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WIRE CUTTER 220MM |
| Generic Name | CUTTER,WIRE |
| Product Code | HXZ |
| Date Received | 2019-04-25 |
| Returned To Mfg | 2019-03-04 |
| Catalog Number | 391.930 |
| Lot Number | T993403 |
| 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 | 2019-04-25 |