MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR ANTEGRADE STANDARD LOCKING; GUIDE

Catalog Number	03.010.049
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Device is an instrument and is not implanted/explanted.A device history record review was requested.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
It was reported that during a open reduction and internal fixation (orif) of the right femur, a drill bit could not align with the nail through the aiming arm.The surgeon freehand the drilling the locking screws and completed the surgery successfully.There was a one minute delay in surgery as the surgeon decided to freehand.The patient was reported to be in great condition following the procedure.Reported concomitant devices unknown drill bit (part number unknown, lot number unknown, quantity: 1) and unknown nail (part number unknown, lot number unknown, quantity: 1).(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.It was reported that during an open reduction and internal fixation (orif) of the right femur, a drill bit could not align with the nail through the aiming arm.The returned insertion handle, aiming arm, drill sleeve and protection sleeve all fit together appropriately.There are no functional issues observed with the devices.All of the devices show normal wear from use, which does not impact functionality.Further functional testing is not possible as the drill bit and the concomitant nail were not returned.The complaint condition was unable to be confirmed or replicated.The following drawings were reviewed during investigation.Dimensional inspection is not relevant as the returned devices interact appropriately.No definitive root cause was able to be determined; however it is possible that intraoperative forces contributed to the complaint condition.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 including material and material properties that would contribute to this complaint condition.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Device history records review was conducted.The report indicates that the: device history lot : part no.: 03.010.049.Lot no.: 3290266.Manufacturing location: (b)(4).Release to warehouse date: 20.Nov.2009.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.Device 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: AIMING ARM FOR ANTEGRADE STANDARD LOCKING
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7388833
• Report Number: 2939274-2018-51374
• Device Sequence Number: 238793
• Product Code: FZX
• UDI-Device Identifier: 10886982067210
• UDI-Public: (01)10886982067210(10)3290266
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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: 03.010.049
• Device Lot Number: 7707344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 107