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 2017-04-27 for WIRE-BENDING PLIERS 160MM 391.82 manufactured by Synthes Tuttlingen.
[73906786]
Device was used for treatment, not diagnosis. Additional narrative: while performing the investigation, it was found that the device was broken. Device is an instrument and is not implanted/explanted. (b)(6). A device history record review was performed for the subject device lot. Manufacturing date: 08-mar-2010. 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 review of inspection records and certifications, confirm that the components and final product met inspection records. All (b)(4) parts of the lot were checked 100% for important features and for function at the final inspection on 05-mar-2010. No nonconformances were generated during production. A product development investigation was performed for the subject device. The 391. 82 lot number t942912 wire-bending pliers was returned and reported to have a sharp edge. This complaint condition was likely caused by over seven years of consistent use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency. A visual inspection and drawing review were performed as part of this investigation. This complaint is confirmed. The cutting edge of the device was determined to be broken leaving a sharp edge. The 391. 82 wire-bending pliers are an instrument routinely used in the small fragment locking compression (lcp) system (technique guide). The device was returned and reported to have a sharp edge. This condition is confirmed; the carbide insert of the cutting edge is broken and missing a fragment leaving a sharp edge behind. The fragment was not returned. The device was manufactured in 3/2010 and is over seven years old. The balance of the returned device is in otherwise fair condition with some superficial wear. Drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended. The condition of the returned device does agree with the complaint description. Whether the complaint condition for this device can be replicated is not applicable for this condition. All measurements have been performed by calipers. During the investigation no product design issues or discrepancies were observed that may have contributed to the 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
[73906787]
(b)(4) reported that a pair of wire bending pliers were noted by instrument room staff to have a sharp edge on the device. It is unknown if the device was used in or impacted a surgical procedure prior to the malfunction being noted. There were no adverse events reported due to the use of this device. There is no additional information available. This is report number 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680938-2017-10071 |
| MDR Report Key | 6527146 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-27 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-03-10 |
| Date Mfgr Received | 2017-04-25 |
| Device Manufacturer Date | 2010-03-08 |
| Date Added to Maude | 2017-04-27 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| 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-BENDING PLIERS 160MM |
| Generic Name | PLIERS,SURGICAL |
| Product Code | HTC |
| Date Received | 2017-04-27 |
| Returned To Mfg | 2017-04-19 |
| Catalog Number | 391.82 |
| Lot Number | T942912 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-27 |