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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part number 03.211.005 lot number t959323.Manufacturing date: 30-mar-2011.Review of the device history record of (b)(4) 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 important features, for function and according to the drawing at the final inspection on 29-mar-2011.No ncrs 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.

Event Description

It was reported that the sales consultant was looking through the 2.4/2.7 variable angle (va) locking compression plate (lcp) tray and discovered that the clover leaf tooth in the head of the pliers was broken off and is missing.There was no surgical or patient involvement.His complaint involves one device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed on the returned device (2.4/2.7 mm variable angle-lcp bending plier, part #: 03.211.005, lot #: t959323).The subject device was returned and reported that the clover leaf tooth was broken off and missing.This complaint condition was likely caused by over five 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 visual inspection, functional test, and drawing review were performed as part of this investigation.This complaint is confirmed.The 03.211.005 2.4 mm/2.7 mm variable angle lcp bending pliers are an instrument routinely used in the 2.4 mm/2.7 mm variable angle lcp forefoot/midfoot system.The device was returned and reported that the clover leaf tooth was broken off and missing.This condition is confirmed; the distal ¿+¿ shaped tooth appears to have sheared off the jaw of the device.It is likely that over five years of consistent use and possible rough handling has led to this complaint condition.The device was manufactured in 3/2011 and is over five years old.The balance of the returned device is in otherwise fair condition with some markings, discoloration, and signs of visible wear.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.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.

• Brand Name: 2.4/2.7MM VA-LCP BENDING PLIER
• 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: 6198400
• MDR Text Key: 63091029
• Report Number: 9680938-2016-10187
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.211.005
• Device Lot Number: T959323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2011
• 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