MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC AIM-ARM F/TIBNAIL; GUIDE

Catalog Number	03.010.052
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Physical product investigation is not be completed; no conclusion could be drawn, as no product was received.Device history record: manufacturing location: (b)(4).Release to warehouse date: september 27, 2005.No non-conformance reports 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 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 an aiming arm would not screw on correctly during an intramedullary (im) tibial nail procedure on (b)(6) 2017.This caused misalignment with the nail.The nail had been inserted when the aiming arm was being used to drill pilot holes.When the misalignment was noticed, another device was obtained from another tray.There was a reported surgical delay of five minutes to obtain another device.No additional medical intervention or additional x-rays were required.The final construct was an im tibial nail and screws.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: 10 mm ti cannulated tibial nail-ex/345 mm-sterile (part # 04.004.449s, lot # unknown, qty # 1).Standard insertion handle (part # 03.010.045, lot # unknown, qty # 1).This complaint involves one (1) device.This report is for the aiming arm.This report is 1 of 1 for (b)(4).

• Brand Name: AIM-ARM F/TIBNAIL
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7158001
• Report Number: 2939274-2018-50018
• Device Sequence Number: 13690472
• Product Code: FZX
• UDI-Device Identifier: 10886982067241
• UDI-Public: (01)10886982067241(10)1382247
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2017

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: 03.010.052
• Device Lot Number: 1382247
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1