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

Catalog Number 391.962

Device Problem Break (1069)

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

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the service history records has been requested.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 at the back table during a metacarpal fracture surgery, while the surgeon was cutting the plate to the correct size needed, the bending/cutting pliers broke.The cutting portion of the pliers broke and a small fragment fell onto the operating room floor and was not retrieved.Surgeon choose another pin cutter that was available in the operating room to complete the surgery.Due to this event no additional time was added.Surgery was completed successfully and patient status was reported as good.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

A service history of the past three years for part number 391.962 with lot number(s) a7fa20/xa7fa20 has been reviewed.No service history review can be performed as the item has not previously been sent in for service.There is no relevant information to the current complained issue.The manufacture date of this item is sometime during the week of may 19, 1996.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Manufacturing date: week 20 in 1996.The device history record is no longer available due to the age of the instrument (over 20 years old).The exact date of manufacture is unknown.A service and repair evaluation was completed: the customer reported the cutting part of the pliers broke.The repair technician reported the tips of the pliers were broken and worn, the pivot area was loose, and the cutting area was broken.Tip broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.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

Product investigation summary: the bending/cutting pliers (part: 391.962 / lot: a7fa20) was returned and reported to have broken during surgery.This complaint condition was likely caused by over twenty (20) years of consistent use; however, this complaint is not likely a result of any design or manufacturing related deficiencies.A visual inspection, functional test, and drawing review were performed as part of this investigation.This complaint is confirmed.The bending/cutting pliers is an instrument routinely used in the 2.7mm variable angle locking calcaneal plating system.The device was returned and reported to have broken during surgery.This condition is confirmed as the distal tip of the textured bending surface and a piece of the carbide cutting surface are no longer attached to the device.It is likely that over twenty (20) years of consistent use has led to this complaint condition.The device was manufactured in may, 1996.The balance of the returned device is in fairly worn condition.The relevant drawing number 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.Upon review of the device history record, no non-conformance reports relevant to the complaint condition were generated during the production of this device.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.

• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5664313
• MDR Text Key: 45437725
• Report Number: 9680938-2016-10072
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• 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: XA7FA20
• Other Device ID Number: (01)10886982198525(10)XA7FA20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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