MAUDE Adverse Event Report: SYNTHES TUTTLINGEN LOCKING PLIERS-LONG; PLIERS,SURGICAL

Catalog Number 359.224

Device Problems Break (1069); Material Separation (1562)

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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Part number: 359.224, synthes lot number: t941517: release to warehouse date: (b)(6) 2009.Mfg.Site: monument.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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 on (b)(6) 2016, during sterile processing, the locking pliers - long were found to have a portion broke off where the locking mechanism is located.The date of the breakage is unknown.There was no patient involvement reported.This is report number 1 of 1 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The 359.224 lot number t941517 locking pliers were returned and reported to have become broken.A visual inspection, functional test, and drawing review were performed as part of this investigation.This condition is confirmed; a pin within the locking mechanism has broken off and was not returned causing another component of the locking mechanism to become detached.The device was manufactured in 12/2009 and is over six years old.The balance of the returned device is in fairly worn condition with several markings and other signs of wear along its length.All measurements have been performed by calipers.Whether the complaint condition for this device can be replicated is not applicable for this condition.The 359.224 locking pliers are an instrument routinely used in the titanium elastic nail system (per technique guide).Relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.This complaint condition was likely caused by over six 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.A corrected device history record review was performed.Review of the device history record 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 critical features and for function at the final inspection on 04-dec-2009.No nonconformances were generated during production.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LOCKING PLIERS-LONG
• Type of Device: PLIERS,SURGICAL
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen CO 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen CO 78532 ; GM 78532
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5955707
• MDR Text Key: 54998002
• Report Number: 1719045-2016-10686
• Device Sequence Number: 1
• Product Code: HTC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 359.224
• Device Lot Number: T941517
• Other Device ID Number: (01)10886982197252(10)T941517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2009
• 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