MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-04-07 for BENDING/CUTTING PLIERS 391.962 manufactured by Synthes Tuttlingen.
[72277545]
Additional narrative: date device was chipped is not known. Device is an instrument and is not implanted/explanted. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. The customer reported the jaw inserts needed replacing. The repair technician reported the jaws had a chip missing out of them. Damaged component is the reason for repair. The item is not repairable per the inspection sheet. The cause of the issue is unknown. The item will be forwarded to customer quality. The evaluation was confirmed. Part 1 of 1. No service history review can be performed as part number 391. 962 with lot number(s) t942349 is a lot/batch controlled item. The manufacture date of this item is 15-dec-2009. The source of the manufacture date is the release to warehouse date. The service history review is unconfirmed. 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 11-dec-2009. No ncrs were generated during production. Manufacturing date: 11-dec-2009. 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
[72277546]
It was reported the jaw inserts of the bending/cutting pliers needed to be replaced. During the service evaluation of the device it was noted the jaws had a chip missing. There was no reported patient or procedure involvement. This report is for one (1) bending/cutting pliers. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[74627129]
Additional narrative: a product investigation was performed on the returned subject device. A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation. This complaint is confirmed. The 391. 962 lot number t942349 bending/cutting pliers were returned and reported to need jaw inserts to be replaced. 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. The 391. 962 bending/cutting pliers is an instrument routinely used in the 2. 7mm variable angle locking calcaneal plating system per relevant technique guide. The device was returned and reported to need jaw inserts to be replaced. This condition is confirmed; one of the inserts inside the device jaws is missing two small fragments that are each approximately a millimeter square. The device was manufactured in 12/2009 and is over seven years old. The balance of the returned device is in fairly worn condition with some superficial wear. Relevant 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. During the investigation no product design issues or discrepancies were observed that may have contributed to the 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
| Report Number | 9680938-2017-10063 |
| MDR Report Key | 6474186 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-07 |
| Date of Report | 2017-02-27 |
| Date Mfgr Received | 2017-04-12 |
| Device Manufacturer Date | 2009-12-11 |
| Date Added to Maude | 2017-04-07 |
| 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 | BENDING/CUTTING PLIERS |
| Generic Name | PLIERS,SURGICAL |
| Product Code | HTC |
| Date Received | 2017-04-07 |
| Returned To Mfg | 2017-03-09 |
| Catalog Number | 391.962 |
| Lot Number | T942349 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-04-07 |