MAUDE Adverse Event Report: SYNTHES TUTTLINGEN 2.4/2.7MM VA-LCP BENDING PLIER; PLIERS, SURGICAL

Catalog Number 03.211.005

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.(b)(6).The device is expected to be returned.Not yet received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device manufacture date unknown.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.

Event Description

It was reported that on (b)(6) 2016 the instrument broke during surgery for bending plate.No prolongation of the surgery reported.Additional information received on (b)(6) 2016 reported that the tip of the pliers broke into two pieces.The procedure was successfully completed.Concomitant part: unknown plate.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (part number 03.211.005, lot number t974416).The subject device was returned with the complaint condition stating the tip of the pliers broke into two pieces while bending plate during surgery.No prolongation of the surgery reported.The procedure was successfully completed.The investigation has shown that one prong of the bending pliers (including the distal bending feature - cloverleaf pin) is broken off as complained.The broken off part was not returned.The instrument is in good condition and presents only normal signs of use.The review of the production history revealed that this instrument was manufactured in june 2012 according to the specifications.The components and final product met inspection records, certification test values and acceptance criteria.The hardness was measured at the time of manufacturing for stainless steel 1.4112 at 55,5 hrc and was found to be good.No manufacturing related issues that would have contributed to this complaint condition were found.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances and we have to assume that high applied mechanical force led to the breakage.A device history record review was performed for the subject device; part # 03.211.005, lot number: t974416: date of manufacture: june 4, 2012.Mfg.Site: (b)(4).The review showed that there were no issues during the manufacture of the 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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date received by manufacturer populated in supplement medwatch report #(b)(4) was reported as sep 6, 2016 in error.The correct date is oct 17, 2016 which corresponds with the date the manufacturing investigation of the subject device was reviewed and approved for completion.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.4/2.7MM VA-LCP BENDING PLIER
• Type of Device: PLIERS, SURGICAL
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen PA 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5930191
• MDR Text Key: 53969351
• Report Number: 2520274-2016-14441
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 03.211.005
• Device Lot Number: T974416
• Other Device ID Number: 01)10886982076038(10)T974416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2012
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN PLATE