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

Catalog Number 391.962

Device Problems Break (1069); Difficult to Open or Close (2921); Naturally Worn (2988)

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

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Service history review: part no.391.962, serial/lot no: (b)(4): no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 14may2014.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.A service and repair evaluation was completed: the customer reported the tip did not close all the way.The repair technician reported the tip was fine, but the cutting feature was very worn and broken down.Worn out parts is the reason for repair.The item is not repairable.The cause of the issue is unknown.The item will be forwarded to the complaint handling unit.The evaluation was unconfirmed.A product investigation was completed: per the technique guides, the bending/cutting pliers are a common trauma instrument utilized to cut and/or contour a plate to the patient¿s anatomy.The returned instrument was examined and the carbide insert for plate cutting on the upper handle was missing (approximately 8mm x 2mm) and not returned.No definitive root cause was able to be determined; the failure mode is consistent with the application of excessive forces and/or improper technique.Relevant drawings for the returned instrument were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.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.

Event Description

It was reported that the tip of the bending/cutting pliers does not close all the way.This was found intra-operatively, no negative impact to the patient and no delay in surgery.Surgeon was able to use another set.When the device was being evaluated by the manufacture, it was noted the tip was fine, but the cutting feature was very worn and broken down.This is report 1 of 1 for (b)(4).

• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5315479
• MDR Text Key: 34025094
• Report Number: 9680938-2015-10131
• Device Sequence Number: 1
• Product Code: HTC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• 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: T102928
• Other Device ID Number: (01)10886982198525(10)T102928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2014
• 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