MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-03-18 for LOCKING PLIERS 359.204 manufactured by Synthes Tuttlingen.
[4236940]
It was reported that during a hardware removal procedure, the back end of the flat nosed pliers broke off. The pin that holds the ratcheting portion to the handle appears to have sheared off. It was reported that another pair of pliers was available to complete the procedure. There were no broken fragments reported. The procedure was successfully completed with no patient injury reported. There was no operative delays. This is report 1 of 1 for this event, complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11667938]
The hardware removal procedure was performed the week of (b)(6) 2014, exact date is unknown. Device is an instrument and it is not implanted/explanted. 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 material which was delivered as lot #kr85256 and #842678 is corresponding to the specifications. The hardness was measured at the time of the manufacturing between 45,2-48 hrc and was found to be good. No non conformances reports were generated during production. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[11999560]
A service and repair evaluation was completed: the customer reported the item is broken and there are missing pieces. The repair technician reported the ratchet broke off and is missing and the locking pin sheared off. The item is not repairable. The cause of the issue is unknown. This item was forwarded to the complaint handling unit for further investigation. The evaluation was confirmed. 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
[12195621]
Additional narrative: a manufacturing evaluation was completed: the locking plier has sheared off but was not received. The pin holding the plier is missing too. The manufacturing evaluation shows that there were no issues during the manufacture of the product that 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
[15884219]
Manufacturer received device but there was no complaint reference number with device. Device has been identified as being associated with this event. Date manufacturer received device is unknown. 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 | 9680938-2014-10003 |
| MDR Report Key | 3685765 |
| Report Source | 05,07 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-02-20 |
| Date Mfgr Received | 2014-08-26 |
| Device Manufacturer Date | 2011-07-19 |
| Date Added to Maude | 2014-05-19 |
| 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 | 0 |
| Event Location | 0 |
| 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 | LOCKING PLIERS |
| Generic Name | PLIERS,SURGICAL |
| Product Code | EML |
| Date Received | 2014-03-18 |
| Returned To Mfg | 2014-03-11 |
| Catalog Number | 359.204 |
| Lot Number | T960577 |
| 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 | 2014-03-18 |