MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-12-21 for BENDING PLIERS FOR 3.5MM CLAVICLE PLATES/227MM LENGTH 329.291 manufactured by Synthes Tuttlingen.
[34018202]
Additional narrative: event date: unknown. 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. 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
[34018203]
It was reported that during a routine field equipment inspection of a modular clavicle set, it was discovered that the screw was missing on the bottom of the pliers. There was no procedure or patient involvement. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[35760548]
Device history records was conducted. The report indicates that the: manufacturing date: jan 29th, 2010 part#: 329. 291, lot#: t943130, review of the device history records showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. The photo and the complaint description show that the screw is missing but the threads were checked at the final inspection of the device on 29th january 2010 and found to be conforming. 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
[37125076]
Product investigation summary: the complaint condition for the bending pliers (part 329. 291 / lot t943130) was likely caused by the tightening screw being lost upon disassembly in sterile processing; however, this complaint is not likely a result of any design related deficiency. The bending pliers are an instrument routinely used in the 3. 5mm lcp superior anterior clavicle plates system. The device was returned and reported to have been found without the screw in the bottom handle of the pliers. This condition is confirmed as the tightening screw was not returned with the device. It is likely that the screw was lost upon disassembly during sterile processing leading to this complaint condition. The device was manufactured in january, 2010 and is six (6) years old. The balance of the returned device is in fair working condition consistent with six (6) years of use. The associated drawing number 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. No non-conformance reports were generated during the production of this device. The complainant part was actually received by the manufacturer for evaluation on december 18, 2015. Field updated with new date of receipt. 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
| Report Number | 9680938-2015-10130 |
| MDR Report Key | 5315362 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-12-21 |
| Date of Report | 2015-12-04 |
| Date Mfgr Received | 2016-01-19 |
| Device Manufacturer Date | 2010-01-29 |
| Date Added to Maude | 2015-12-21 |
| 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 | 2015-12-21 |
| Returned To Mfg | 2015-12-18 |
| Catalog Number | 329.291 |
| Lot Number | T943130 |
| ID Number | (01)10886982191946(10)T943130 |
| 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 | 2015-12-21 |