MAUDE Adverse Event Report: SYNTHES TUTTLINGEN ROD/PLATE BENDER

Catalog Number	03.614.022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Manufacturing date: may 28, 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 parts of the lot were checked 100% for important features and for function at the final inspection.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) reported that during an unknown cervical spine procedure on (b)(6) 2017, while the surgeon was using a synthes rod bender, a piece of the bender broke off.There was reportedly a five minute surgical delay.The procedure was completed with a similar/like product.Concomitant devices reported: unknown synthes rod (part unknown, lot unknown, quantity 1).This is report 1 of 1 for com-(b)(4).
Additional Manufacturer Narrative
Product development investigation has been completed.A visual inspection, functional test, and drawing review were performed as part of this investigation.The rod/plate bender in available in the synapse system where it is utilized to contour rods to better fit patient anatomy.It was reported the piece of the bender broke off and after visual inspected it was determined that one of the set screws and one of the rollers fell apart from the device as the instrument shows no sign of being broken/sheared off.Replication of the complaint condition is not applicable as the pieces were not returned/missing and the complaint is confirmed.Relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision).Relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision).Review of inspection records and certifications, confirm that the components and final product met inspection records.All 32 parts of the lot were checked 100% for important features and for function at the final inspection on 27-may-2010.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The exact cause was unable to be determined; a possible could be the instrument was taken apart for sterilization and not tightened enough causing it to fall apart during the procedure.The set screw is locked in place and is not supposed to be taken apart.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: ROD/PLATE BENDER
• Common Device Name: BENDER
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6345991
• Report Number: 9680938-2017-10024
• Device Sequence Number: 861399
• Product Code: HXW
• UDI-Device Identifier: 10705034714936
• UDI-Public: (01)10705034714936(10)T946895
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2017

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: 03.614.022
• Device Lot Number: T946895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 03/28/2017
• 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: 1 UNKNOWN SYNTHES ROD