MAUDE Adverse Event Report: SYNTHES TUTTLINGEN COMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES; PLIERS, SURGICAL

Catalog Number	391.965
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: nov 11, 2005.The review showed that there were three (3) different manufacturing lots under a7oa45: ba# 903322, ba# 903324, and ba# 903316.The review of all three lots showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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
It was reported that during a mid-face orbital floor blowout procedure on (b)(6) 2017, while the surgeon was bending the plate on the back-table, the tension spring broke near the main frame of the combination bending/cutting pliers and fell out.The surgeon easily retrieved the spring.Since this event occurred at the back table, the spring did not fall into the patient¿s wound.The surgeon finished the procedure with a readily available back-up device.There was no surgical time delay or harm to the patient.Concomitant medical products: unknown plate - part# - unknown, lot# - unknown, quantity# - 1.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation has been completed.A visual inspection, drawing review and dhr review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.The combination bending/cutting pliers were confirmed to have a broken leaf spring.The spring broke where it is screwed into the handle.The device shows normal surface wear from over 11 years of use.Relevant drawings were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The device is over 11 years old and the leaf spring likely weakened due to numerous use and sterilization cycles.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: COMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES
• Common Device Name: PLIERS, SURGICAL
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6390210
• Report Number: 9680938-2017-10037
• Device Sequence Number: 454605
• Product Code: HTC
• UDI-Device Identifier: 10887587041032
• UDI-Public: (01)10887587041032(10)A70A45
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2017

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: 391.965
• Device Lot Number: A70A45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 04/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ONE UNKNOWN PLATE, QUANTITY 1