MAUDE Adverse Event Report: SYNTHES HAGENDORF PERCUTANEOUS INSERTION HANDLE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.046
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
Patient information not available for reporting.Date of device breakage is not known.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: 22.May.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 the insertion handle was discovered broken prior to the start of surgery on (b)(6) 2017.The piece at the tip of the insertion handle that comes in contact with the nail had broken off.The patient had been wheeled into the operating room; however, the device did not come near the patient.The piece that broke off could not be located.This report is for one (1) percutaneous insertion handle.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 tang/tab that aligns with the implant (nail) has sheared off of the returned insertion handle.The tang/tab that sheared off at its base 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.The returned percutaneous insertion handle is a reusable instrument available for use in the lateral entry femoral nail-ex instrument set 01.003.300 per product support material.The device is used to insert lateral entry femoral nails percutaneous.A dimensional inspection of the tab feature was not able to be performed because the tang sheared off at its base and was not returned.Drawing was reviewed during this investigation.No product design issues or discrepancies were observed.This investigation was unable to determine a root cause.It was determined that the malfunction occurred most likely due to application of excessive force while not seated securely in the nail causing overload to the distal tang/tab.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: PERCUTANEOUS INSERTION HANDLE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6530449
• Report Number: 3003875359-2017-10203
• Device Sequence Number: 530864
• Product Code: LXH
• UDI-Device Identifier: 10886982067180
• UDI-Public: (01)10886982067180(10)9326867
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/05/2017

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: 03.010.046
• Device Lot Number: 9326867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1