MAUDE Adverse Event Report: SYNTHES HAGENDORF RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/175MM; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.487
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing location: (b)(4); manufacturing date: 28.Mar.2015.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
It was reported that a radiolucent insertion handle for expert nails broke while forcefully rotating the patient¿s leg during an initial intramedullary nailing of the left femur procedure on (b)(6) 2017.Fragments generated from the broken device were retained in patient and surgeon did not attempt to retrieve the fragments.Procedure was successfully completed without surgical delay.No other medical intervention required.This report is for one (1) radiolucent insertion handle for expert nails.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.This complaint is confirmed.The alignment tab has sheared off the returned insertion handle as reported.The tab sheared off at its base and was not returned.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.Relevant drawing was reviewed.No product design issues or discrepancies were observed.No definitive root cause could be determined.It was determined that the incident most likely occurred due to excessive force on instrument - per the complaint description "insertion guide alignment tab broke while forcefully rotating a patient¿s leg during intramedullary nailing".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: RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/175MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6544351
• Report Number: 3003875359-2017-10214
• Device Sequence Number: 133974
• Product Code: LXH
• UDI-Device Identifier: 10886982069054
• UDI-Public: (01)10886982069054(10)8806943
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/08/2017

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: Health Professional
• Device Catalogue Number: 03.010.487
• Device Lot Number: 8806943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Weight: 91