MAUDE Adverse Event Report: SYNTHES SELZACH BONE HOOK-SHAPE ARM 206MM; MISC ORTHO SURGICAL INSTR

Catalog Number	398.756
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is an instrument and is not implanted / explanted.(b)(4).Device history records review was completed for part# 398.756, lot# 10-2549.Manufacturing location: (b)(4), manufacturing date: nov 03, 2010.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.The device was received and the product evaluation is in progress.No conclusion can be drawn.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 on (b)(6) 2017, during the procedure, the surgeon used the collinear reduction clamp to get a liss distal femur plate against the bone.After some struggle due to the patient's soft tissue the surgeon had the plate against the femur using the collinear clamp.After a few minutes it was noticed that the hook portion of the bone hook shaped arm had detached in 2 large pieces.The surgeon was able to retrieve the piece within two minutes with 2-3 additional fluoroscopies.The procedure was completed successfully.Patient outcome was reported as stable.Concomitant devices reported: collinear reduction clamp (part# unknown, lot# unknown, quantity 1); liss femur plate (part# unknown, lot# unknown, quantity 1).This report is for one (1) bone hook-shape arm 206mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was completed: the returned instrument was evaluated at customer quality and the complaint was able to be confirmed.The hook component of the bone hook-shape arm had broken off cleanly from the body at the weld.Although the definitive root cause could not be determined, it is likely that wear over 6+ years of use as well as excessive cantilever force contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.Replication of the complaint is not applicable as the complaint condition was dimensionally confirmed.This complaint is confirmed.No new malfunctions were identified during the investigation.Per the technique guide, the sliding mechanism is used in conjunction with one of the four attachment arms to construct the collinear reduction clamp.This clamp is intended to assist in achieving and maintaining fracture reduction in minimally invasive techniques.Relevant product drawings were reviewed.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.A device history review was performed for the returned instruments¿ lot numbers and in each instance no material review reports, non-conformance reports or complaint-related issues were identified with the lots numbers which may have contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: BONE HOOK-SHAPE ARM 206MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• MDR Report Key: 6369904
• Report Number: 3000270450-2017-10065
• Device Sequence Number: 16254104
• Product Code: LXH
• UDI-Device Identifier: 10886982201591
• UDI-Public: (01)10886982201591(10)10-2549
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 398.756
• Device Lot Number: 10-2549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 04/03/2017
• 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 (1) UNKNOWN COLLINEAR REDUCTION CLAMP; ONE (1) UNKNOWN LISS FEMUR PLATE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 193