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

Additional narrative: event date: unknown.Device is an instrument and is not implanted/explanted.Manufacturing date: may 04, 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 parts of the lot were checked 100% for features and for function at the final inspection.No non-conformance reports were generated during production.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.

Event Description

It was reported that while inspecting field equipment, the reporter noticed that the tip of the bending pliers, the part that keys into the plate, was broken off.The broken tip of the device was not found.There was no patient or surgical involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.One 2.4/2.7mm variable angle locking compression plate (va-lcp) bending plier (part number 03.211.005 / lot number t960935) was received.A visual inspection and drawing review were performed as part of this investigation.The complaint condition is confirmed as the device was received with the cloverleaf protrusion on the distal tip of the pliers sheared off.The broken portion was not received.A dent was observed on one side of the distal tip.The balance of the returned device is in fair condition, consistent with use, with some markings and signs of wear along the length of the pliers.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.(all dimensional inspections completed with calipers ca102p) the 2.4/2.7mm variable angle locking compression plate (va-lcp) bending plier is mentioned in the 2.7mm va locking calcaneal plating system technique guide and the 2.4mm /2.7mm va- lcp forefoot/midfoot system technique guide.The instrument is used to contour variable angle plates to better accommodate a patient¿s anatomy.Its clover leaf shape design protects the variable angle holes during contouring by aligning the cloverleaf protrusion on the pliers with the cloverleaf design in the plate.Two pliers are required to contour the plate.A review of the current design drawing / manufactured revision for the assembly and the bottom distal component was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.A definitive root cause could not be determined given the unknown circumstances at the time of the issue.The returned condition is consistent with exposure to high forces and cyclic loading which permitted the fracture of cloverleaf protrusion on the distal tip.Manufacturing date: 29-apr-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 ctq features and for function at the final inspection on 28-apr-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.

• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5994780
• MDR Text Key: 56339322
• Report Number: 9680938-2016-10154
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 03.211.005
• Device Lot Number: T960935
• Other Device ID Number: (01)10886982076038(10)T960935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2011
• 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