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 01/08/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient id, age, dob & weight not provided for reporting.Implant and explant dates: device is an instrument and is not implanted/explanted.Concomitant device reported: synthes 2.4mm/2.7mm variable angle locking compression plate (lcp), part # 02.211.252, unknown lot #, quantity x 1.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: manufacturing location: part 03.211.005/ lot t957352, manufacturing date: 08-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 32 parts of the lot were checked 100% for important features and for function at the final inspection on 08-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 on (b)(6) 2017 the patient underwent an open reduction internal fixation (orif) procedure of the left distal humerus to treat a fracture.During the case while the surgeon was trying to bend a synthes 2.4mm/2.7mm variable angle locking compression plate (lcp), the bending pliers broke at the most proximal plate holding post within the pliers.There was (1) fragment that was easily retrieved without intervention.These events resulted in a 15 minute no surgical delay.There was no alternate instrument.The surgeon used the malfunctioned pliers to complete the procedure.There was no harm to patient.The procedure was successfully completed and the patient was in stable condition at the end of the case.This complaint involves 1 device.Concomitant device reported: synthes 2.4mm/2.7mm variable angle locking compression plate (lcp), part # 02.211.252, unknown lot #, quantity x 1.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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

Additional narrative: product investigation was completed for part # 03.211.005, lot # t957352.A visual inspection, device history records review, and drawing review were performed as part of this investigation.A 2.4mm/2.7mm va lcp bending pliers was returned and reported to have broken during surgery.This complaint is confirmed; the proximal x-shaped post has sheared off at a diagonal slant.The balance of the returned device is in fairly worn condition with markings and signs of wear along its length.The 03.211.005 2.4mm/2.7mm va lcp bending pliers are an instrument routinely used in the 2.7mm variable angle locking calcaneal plating system.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.It is likely that over five years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.The device was manufactured in 3/2011 and is over five years old.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: 6281181
• MDR Text Key: 65907064
• Report Number: 9680938-2017-10010
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10886982076038
• UDI-Public: (01)10886982076038(10)T957352
• 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: 01/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: T957352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2017
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/27/2017; 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2011
• 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
• Patient Age: 41 YR