MAUDE Adverse Event Report: SYNTHES TUTTLINGEN REDUCTION FORCEPS FOR 1.3 TO 2.0MM SCREWS/SOFT LOCK

Catalog Number	03.130.291
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 critical features and for function at the final inspection on 26-oct-2016.No ncrs were generated during production.Manufacturing date: 26-oct-2016.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 europe reports an event in (b)(6) as follows: it is reported during a procedure to repair a fracture of the fifth metacarpal on (b)(6) 2017, the reduction forceps would not attach to the bone.As surgeon attempted to apply the device to insert the lag screw, the device slid when surgeon attempted to close it.Surgery was delayed approximately 30 minutes.Concomitant devices reported: screw (part number unknown, lot number unknown, quantity unknown).This report is for one (1) reduction forceps.This is report 1 of 1 for (b)(4).

• Brand Name: REDUCTION FORCEPS FOR 1.3 TO 2.0MM SCREWS/SOFT LOCK
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6545808
• Report Number: 9680938-2017-10073
• Device Sequence Number: 750148
• Product Code: HTD
• UDI-Device Identifier: 07611819690752
• UDI-Public: (01)07611819690752(10)T137201
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 04/07/2017

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: 03.130.291
• Device Lot Number: T137201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 05/04/2017
• 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: SCREW (PART AND LOT UNKNOWN, QTY UNKNOWN)