MAUDE Adverse Event Report: SYNTHES TUTTLINGEN WIRE-BENDING PLIERS 160MM; PLIERS,SURGICAL

Catalog Number	391.82
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: while performing the investigation, it was found that the device was broken.Device is an instrument and is not implanted/explanted.(b)(6).A device history record review was performed for the subject device lot.Manufacturing date: 08-mar-2010.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 important features and for function at the final inspection on 05-mar-2010.No nonconformances were generated during production.A product development investigation was performed for the subject device.The 391.82 lot number t942912 wire-bending pliers was returned and reported to have a sharp edge.This complaint condition was likely caused by over seven years 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.A visual inspection and drawing review were performed as part of this investigation.This complaint is confirmed.The cutting edge of the device was determined to be broken leaving a sharp edge.The 391.82 wire-bending pliers are an instrument routinely used in the small fragment locking compression (lcp) system (technique guide).The device was returned and reported to have a sharp edge.This condition is confirmed; the carbide insert of the cutting edge is broken and missing a fragment leaving a sharp edge behind.The fragment was not returned.The device was manufactured in 3/2010 and is over seven years old.The balance of the returned device is in otherwise fair condition with some superficial 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.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
(b)(4) reported that a pair of wire bending pliers were noted by instrument room staff to have a sharp edge on the device.It is unknown if the device was used in or impacted a surgical procedure prior to the malfunction being noted.There were no adverse events reported due to the use of this device.There is no additional information available.This is report number 1 of 1 for complaint (b)(4).

• Brand Name: WIRE-BENDING PLIERS 160MM
• Common Device Name: PLIERS,SURGICAL
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6527146
• Report Number: 9680938-2017-10071
• Device Sequence Number: 16365007
• Product Code: HTC
• UDI-Device Identifier: 10886982198310
• UDI-Public: (01)10886982198310(10)T942912
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 391.82
• Device Lot Number: T942912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1