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

Catalog Number 03.010.052

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 12/05/2017

Event Type  malfunction  

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 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
• Type of Device: GUIDE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7158001
• MDR Text Key: 96618569
• Report Number: 2939274-2018-50018
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982067241
• UDI-Public: (01)10886982067241(10)1382247
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.052
• Device Lot Number: 1382247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• Date Device Manufactured: 09/27/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1