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 2019-01-31 for WIRE CUTTER 220MM 391.930 manufactured by Oberdorf Synthes Produktions Gmbh.
[134703563]
A device history record (dhr) review was conducted: part number: 391. 930; synthes lot number: t135588; release to warehouse date: 05-jan-2017; manufacture site: (b)(4); part expiration date: n/a; list of nonconformance? S: 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. The raw material certificate was reviewed and the used material was according to the specification of the device. 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. A product investigation was conducted. Visual inspection: upon visual inspection of the complaint device it can be seen that on the tip section the cutting edges are badly damaged and some bits are chipped off, this thus confirming the complaint description. Furthermore, three (3) of four (4) welding point are broken. Otherwise, the article is in good but well used condition. Functional test: a functional test was performed per 100% (with a 0. 6mm and a 2. 0mm kirschner wires) at the time of manufacturing with no non-conformities documented. Document/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no document/specification review is needed. Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed. Material or hardness review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no material or hardness review is needed. Summary: there is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place, or/and that wrong and/or not allowed material got cut, led to this damage. To prevent such problems, it is necessary worn or damaged instruments to replace and/or to operate according to the technique guide. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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
[134703564]
Device report from synthes reports an event in (b)(6) as follows: it was reported that, the teeth of two (2) large wirecutters were chipped during an unknown surgery on (b)(6) 2019. Another wirecutter was used to complete the procedure. There was no reported surgical delay. Patient outcome is unknown. This report is for one (1) wire cutter 220mm. This is report 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-60527 |
| MDR Report Key | 8292926 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-04 |
| Date of Event | 2019-01-04 |
| Date Mfgr Received | 2019-02-28 |
| Device Manufacturer Date | 2017-01-05 |
| Date Added to Maude | 2019-01-31 |
| 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 | 2019-01-31 |
| Returned To Mfg | 2019-01-29 |
| Catalog Number | 391.930 |
| Lot Number | T135588 |
| 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 | 2019-01-31 |