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 CABLE CUTTER 03.607.513 manufactured by Oberdorf Synthes Produktions Gmbh.
[134591903]
Investigation summary: upon receipt it was noted that the tip of the instrument is broken. Visual inspection: one corner of the front cutter jaw is broken off; the broken off part was not returned for investigation. Material /hardness review: this instrument is made of stainless according to the relevant test instruction the correct material was used, and the hardness parameters were within the specification. Summary: the complaint condition is confirmed as one corner of the cutting jaw is broken off. This production lot (l935233) was manufactured in july 2018 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 hardness was measured for material at the time of manufacturing and was found to comply with specification. The broken surface is homogenous what indicates material conformity as well. There were no issues during the manufacture of this product that would contribute to this complaint condition. The damage occurred is determined to be post production/acceptance criterias and it can be assumed that a mechanical overload during use caused this breakage. Please note: the stopper on the side of the cutter is usually not exposed to any force during the cutting procedure as there is a clear gap between the stopper and the corner in closed position. It is likely that an obstacle of any kind was between the stopper and the corner during the cutting procedure causing a mechanical overload. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Device history lot part: 03. 607. 513, lot: l935233, manufacturing site: (b)(4), release to warehouse date: 07/11/2018. The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted. This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process. According to the relevant test instruction the correct material was used, and the hardness parameters were within the specification review of the device history record(s) showed that there were no issues during the manufacture of this product, which would contribute to this complaint condition. 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
[134591904]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the tip of the front cutter broke after two (2) months. It was unknown when was the issue was discovered. There was no patient consequence reported. This report is for one (1) cable cutter. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-60522 |
| MDR Report Key | 8292673 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-14 |
| Date Mfgr Received | 2019-01-14 |
| Device Manufacturer Date | 2018-07-11 |
| 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 | WERK SYNTHES UMKIRCH |
| Manufacturer Street | IM KIRCHENH |
| Manufacturer City | UMKIRCH BEI FREIBURG 79224 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 79224 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CABLE CUTTER |
| Generic Name | CUTTER,WIRE |
| Product Code | HXZ |
| Date Received | 2019-01-31 |
| Returned To Mfg | 2018-12-21 |
| Catalog Number | 03.607.513 |
| Lot Number | L935233 |
| 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 | 2019-01-31 |