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

Catalog Number 391.962

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records review was completed for part# 391.962, lot# t106165.Manufacturing location: (b)(4), manufacturing date: dec 19, 2014.No non conformance reports were generated during production.A review of inspection records and certifications, confirm that the components and final product met inspection records.All 32 parts of the lot were checked 100% for important features and for function at the final inspection on dec 15, 2014.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

It was reported that a piece from plate cutter/bender broke off.There was no patient involvement.This report is for one (1) bending/cutting pliers.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.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 development investigation has been completed.A visual inspection, device history records review, and drawing review were performed as part of this investigation.This complaint is confirmed.The device was returned and reported that a piece had broken off.This condition is confirmed; one of the two carbide inserts inside the cutting portion of the device is missing and was not returned.It is likely that over two years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.The device was manufactured in 12/2014 and is over two years old.The balance of the returned device is in otherwise fairly good condition with only some superficial wear.Relevant drawing 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.The 391.962 bending/cutting pliers are an instrument routinely used in the 2.7 mm variable angle locking calcaneal plating 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.

• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6360299
• MDR Text Key: 68376784
• Report Number: 9680938-2017-10027
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10886982198525
• UDI-Public: (01)10886982198525(10)T106165
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• 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: T106165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2014
• 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