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

Catalog Number 391.962

Device Problem Dull, Blunt (2407)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: damage to device was noticed on (b)(6) 2016, but is unknown when the damage occurred.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.No service history review can be performed as part number 391.962 with lot number(s) t119274 is a lot/batch controlled item.The manufacture date of this item is 7-may-2015.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Please launch a device history record review (dhr).Manufacturing date: 05-may-2015.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 05-may-2015.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, the patient underwent a metacarpal fracture repair on (b)(6) 2016, and during that procedure the surgeon noted problems with some synthes instruments.The cutting edge of the plate cutter appeared damaged or missing, causing the cutter to bend and deform the plate instead of cutting it.Another similar instrument was readily available to complete the procedure.Additionally, the surgeon noted the screwdriver tip would not retain the screws and when inserting screws, the tip was slipping which caused the screws to strip.Another similar instrument was readily available to complete the procedure.There was no surgical delay reported and no harm was reported to the patient.Concomitant devices reported: plate (part # unknown, lot # unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The customer reported the cutting edge appeared to be damaged or missing.The repair technician reported the cutting jaws/elements were broken.Cutting jaws 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.Subject device has been received and is currently in the evaluation process.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.

Event Description

Concomitant medical products: screw (unknown part and lot numbers, quantity:1).

Manufacturer Narrative

A product development investigation was performed for the subject device (bending/cutting pliers, part number 391.962, lot number t119274).The subject device was returned with the complaint condition stating that the cutting edge was damaged.The 391.962 bending/cutting pliers are an instrument routinely used in the locking calcaneal plate instrument and implant sets.The device was returned and reported that the cutting edge was damaged.This condition is confirmed; one of the carbide inserts is missing from the cutting portion of the device.It is likely that over a year of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.The device was manufactured in 5/2015 and is over a year old.The balance of the returned device is in otherwise fairly good condition without much 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.All measurements have been performed by calipers ca99p.A visual inspection, functional test and drawing review were performed as part of this investigation.This complaint is confirmed.This complaint condition was likely caused by over a year 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.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: 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5953198
• MDR Text Key: 54822127
• Report Number: 9680938-2016-10146
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• 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: T119274
• Other Device ID Number: (01)10886982198525(10)T119274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• 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
• Treatment: PLATE, PART UNKNOWN