MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2015-07-16 for BENDING PLIERS FOR 3.5MM CLAVICLE PLATES/227MM LENGTH 329.291 manufactured by Synthes Tuttlingen.
[6010063]
It was reported that a pair of bending pliers no longer worked properly as they would not bend plates as they should. The issue was reportedly discovered during an inspection prior to a surgical procedure. The patient had not been brought into the operating room at the time; therefore, no patient involvement is assessed for this event. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[14200756]
Additional narrative: device is an instrument and is not implanted or explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Investigation could not be completed and no conclusion could be drawn as no device was returned. Device history review: manufacturing date: october 28, 2009 review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The raw materials, which were delivered as lots 70381, 839003, kr327639, and kr82671, are corresponding to the specifications. The hardness was measured at the time of the manufacturing between 47. 8-48. 0 hrc and was found to be good. No non-conformance reports were generated during production. Device 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
[28616282]
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[30128478]
Additional narrative: a product evaluation was performed. The investigation of the complaint articles indicates that: the 329. 291 bending pliers are an instrument routinely used in the 3. 5mm lcp superior anterior clavicle plates system ((b)(4)). The device was returned and reported to no longer be working properly. This condition is confirmed; the ball bearing in the central lever has corroded to the point at which the stop lever will advance farther down the lever than designed. It is likely that five years of use and sterilization cycles has led to the wear which has led to this complaint condition. The device was manufactured in 10/2009 and is over five years old. The balance of the returned device is in fairly worn condition. A 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 and is not likely a result of any design related deficiency. Whether the complaint condition for this device can be replicated is not applicable for this 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 | 9680938-2015-10063 |
| MDR Report Key | 4918725 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-07-16 |
| Date of Report | 2015-07-06 |
| Date Mfgr Received | 2015-08-18 |
| Device Manufacturer Date | 2009-10-28 |
| Date Added to Maude | 2015-07-16 |
| 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 | LINDA PLEWS |
| 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 PLIERS FOR 3.5MM CLAVICLE PLATES/227MM LENGTH |
| Generic Name | INSTR, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2015-07-16 |
| Returned To Mfg | 2015-07-24 |
| Catalog Number | 329.291 |
| Lot Number | T940955 |
| 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 | 2015-07-16 |