MAUDE Adverse Event Report: SYNTHES TUTTLINGEN BENDING/CUTTING PLIERS; PLIERS, SURGICAL

Catalog Number 391.962

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that two (2) bending/cutting pliers were discovered in sterile processing with the tips broken off.It is unknown on what date the devices were broken.There was no reported patient or surgical involvement or delay.This report is 2 of 2 for com-(b)(4).

Manufacturer Narrative

Device history records was conducted.The report indicates that the: manufacturing date: january 18th, 2016, lot # 391.962, lot t124831.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.All parts were checked 100% for function at the final inspection on (b)(4) 2016.No ncrs were generated during production.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.

Manufacturer Narrative

Product investigation summary: the returned instruments were examined and, in each instance, the complaint conditions were able to be confirmed as the bending jaw carbide inserts were found to be damaged and missing segments: bottom jaw of lot t976874 and both jaws of lot t124831.In each instance, the missing fragments were approximately 2.5mm x 2mm x 0.5mm.No definitive root cause was able to be determined; however, the failure mode is typically associated with rough handling.A device history review was performed for the returned instruments¿ lot numbers with no complaint-related issues identified.The bending/cutting pliers are noted in nine system technique guides including: universal locking trochanter stabilization plate, 1.5mm lcp modular mini fragment, and locking calcaneal plate.In each system, the instrument is available for cutting and contouring of plates to better fit patient anatomy.The relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision): top-level.The design, materials, and finishing processes were found to be appropriate for the intended uses of these devices.A device history review was performed for the returned instruments¿ lot numbers with no material record reports, non-conformance reports, or complaint-related issues identified.No definitive root cause was able to be determined; however, the failure mode is typically associated with rough handling.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.

• Brand Name: BENDING/CUTTING PLIERS
• Type of Device: PLIERS, SURGICAL
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5578538
• MDR Text Key: 42704386
• Report Number: 9680938-2016-10045
• Device Sequence Number: 1
• Product Code: HTC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.962
• Device Lot Number: T124831
• Other Device ID Number: (01)10886982198525(10)T124831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1