MAUDE Adverse Event Report: SYNTHES TUTTLINGEN 2.4/2.7MM VA-LCP BENDING PLIER; PLIERS, SURGICAL

Catalog Number	03.211.005
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted / explanted.(b)(6).Device history records review was completed for part#: 03.211.005, lot#: t989515.Manufacturing location: (b)(4), manufacturing date: jun 18, 2013.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing evaluation has been completed for part#: 03.211.005, lot#: t989515.Visual inspection of the returned device noted that the plate bender exhibits some post production/acceptance wear and tear marks but overall appears to be in good condition.The front pin was broken off.The manufacturing evaluation shows that there were no issues during the manufacturing that would contribute to this complaint condition.The material, hardness, width, length and height of the pin were re-inspected and all were found to be conforming.The exact cause which has led to the breakage of the pin could not be evaluated.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 or Problem Description
Device report from synthes (b)(4) reports an event in (b)(6) as follow: it was reported that on (b)(6) 2016, the small pin in the jaw of pliers, was found loose.Unknown if there was a patient involvement.No information regarding patient involvement or surgery outcome was reported.Upon the receipt of the device at manufacturer, it was found on (b)(6) 2017, that the small pin was broken out of the instrument.It is unknown when and where this pin broke.This report is for one (1) 2.4/2.7 mm va-lcp bending plier.This is report 1 of 1 for com-(b)(4).

• Brand Name: 2.4/2.7MM VA-LCP BENDING PLIER
• Common Device Name: PLIERS, SURGICAL
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6308952
• Report Number: 9680938-2017-10016
• Device Sequence Number: 1159627
• Product Code: HTC
• UDI-Device Identifier: 07611819434790
• UDI-Public: (01)07611819434790(10)T989515
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2016

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: Physician
• Device Catalogue Number: 03.211.005
• Device Lot Number: T989515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2017
• Initial Report FDA Received Date: 02/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1