MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.405
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Reporter¿s phone number is unknown.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during a surgery to treat the sub-trochanteric fracture, the drill hit a nail at the time of drilling after the drill sleeve was inserted into the aiming arm.The surgeon successfully completed the surgery by adjusting the drill angle slightly.The operation was delayed by five (5) minutes and there were no adverse consequences for the patient.Surgeon commented that the connecting screw, insert handle and other parts were firmly connected and bending of the nail was not seen inside the bone.This report is for one (1) radiolucent insertion handle f/trochanteric fixation nails.(b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 03.010.405, lot# 7595881.Manufacturing location: (b)(4), release to warehouse date: nov 25, 2011.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.Product development investigation was completed.The received part has signs of use on its surface.The exact root cause could not be determined as no detailed clinical information and not all involved parts, especially the involved nail, were provided.In addition, complained malfunction could not be reproduced as the device passed the required functional check at customer quality department successfully.The functionality test was performed in collaboration with product development department and with all received parts for this complaint and the corresponding equipment.Due to functional test results, this complaint will be rated as unconfirmed.As this instrument is more than seven years old and this device is foreseen to a multiple use, it can be assumed that the damages were caused due to normal wear and tear over years.Additionally, incorrect handling of the equipment could have led to the issue, e.G.Was not mounted correctly.The cause of failure is not due to any manufacturing non-conformances.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.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 F/TROCHANTERIC FIXATION NAILS
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7282437
• Report Number: 8030965-2018-51222
• Device Sequence Number: 123625
• Product Code: LXH
• UDI-Device Identifier: 07611819349421
• UDI-Public: (01)07611819349421(10)7595881
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: 03.010.405
• Device Lot Number: 7595881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1