MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX; MISC ORTHO SURGICAL INSTR

Model Number	03.010.084
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 on (b)(6) 2019, during an intramedullary nail of a femur, they were doing a retrograde femoral nail on a patient.The prong from the spiral blade inserter for retrograde femoral nails-expert broke off as the spiral blade being inserted.The spiral blade was inserted fine, but, when they try to remove, the spiral blade inserter from the patient was stuck in the aiming arm for retrograde spiral blade locking.They just had it removed the whole handle and as far as the implant in the patient everything was fine.There was a surgical delay of 5 minutes.The procedure was successfully completed and no back up was available.The patient was recovering fine.Concomitant device reported: unk - nails: femoral (part # unknown, lot # unknown, quantity 1).This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The spiral blade inserter for retrograde femoral nails-ex (p/n 03.010.084 lot 1784183) was received jammed/stuck inside the aiming arm and unable to disassemble.One of the two distal prongs were broken off and missing.The intact prong was deformed and bent inwards towards the center of axis.No other issues were identified with the returned components of the device.Functional testing showed that the spiral blade inserter would not disassemble from the aiming arm.The two instruments are jammed/stuck.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The complaint condition is confirmed for the spiral blade inserter for retrograde femoral nails-ex (p/n 03.010.084 lot 1784183) as the instrument was jammed/stuck inside the aiming arm and unable to disassemble.One of the two distal prongs were broken off and missing.The intact prong was deformed and bent inwards towards the center of axis.While no definitive root cause could be determined, it is possible that the spiral blade was jammed from excessive hammer blow force(s) and/or the helix was not aligned.Additionally, the broken off prong and deformed prong may be due to rough handling, unintended forces, and/or consistent use over the part¿s lifetime (11+ years).During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 03.010.084, lot: 1784183, manufacturing site: hägendorf, release to warehouse date: 29.Nov.2007.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8700270
• Report Number: 2939274-2019-58662
• Device Sequence Number: 2473007
• Product Code: LXH
• UDI-Device Identifier: 10886982067548
• UDI-Public: (01)10886982067548
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2019

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 Model Number: 03.010.084
• Device Catalogue Number: 03.010.084
• Device Lot Number: 1784183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 05/19/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/11/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAILS: FEMORAL
• Patient Weight: 77