MAUDE Adverse Event Report: UMKIRCH CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL; MISC ORTHO SURGICAL INSTR

Catalog Number	03.221.010
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.Reporter¿s phone number is (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturing location: (b)(4).Date of manufacture: feb 19, 2015.The review 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
Device report synthes europe reported an event in (b)(6) as follows: it was reported that during surgery on an unknown date, the nut component of the cerclage passer broke while passing the stainless steel wire in the femur.The broken fragments were easily removed from the patient.The procedural step was completed by passing the wire by hand.The surgery was successfully completed without delay and without patient harm.This is report 1 of 1 for com-(b)(4).
Additional Manufacturer Narrative
Additional product code: fsm.(b)(6).A product investigation was completed: upon receipt of the complained instrument it could be confirmed that the tip of the cerclage passer is not broken off as previously mentioned in the device report but one of the tubes is slightly deformed and presents scratches and dents.It was reported, that the nut of passer was broken.This could not be confirmed as the nut is not broken.The review of the production history revealed that this instrument was manufactured in december 2014 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.Furthermore these instruments are function checked per 100% before they leave the manufacturing site.The complaint is determined not to be a result of a detected manufacturer or design deficiency.Based on the investigation we have to assume that too much force while inserting the cerclage passer was applied and caused the deformation of the tube.No product fault could be detected.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: CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• MDR Report Key: 6282535
• Report Number: 3003862213-2017-10003
• Device Sequence Number: 11039413
• Product Code: LXH
• UDI-Device Identifier: 07611819880092
• UDI-Public: (01)07611819880092(10)9207427
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2017

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: 03.221.010
• Device Lot Number: 9207427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2017
• Supplement Report FDA Received Date: 02/28/2017
• 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: UNKNOWN WIRE, QUANTITY UNKNOWN