MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN ROD, FIXATION, INTRAMEDULLARY

Model Number 03.010.482

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Additional medical/surgical intervention required and change in surgical plan: unable to proceed with the recon nail locking option). The device has been 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 Description

It was reported that during a recon nail surgery on (b)(6) 2019, the cannulas of two (2) radiolucent recon aiming arm for expert lateral femoral nail (lfn) were a little bit loose inside. The four (4) guide wires missed the recon nail hole posterior and anterior by quite a bit and because of it surgeon was unable to proceed with the recon nail locking option. Even after locking the largest gold cannula into the radiolucent aiming arm, the surgeon and the sales rep felt as though there was some "wiggle" room or a little bit of toggle that could be the cause of the guidewires missing the nail's recon holes. A few millimeters of toggle could create a misplaced guide wire. There was a surgical delay of 5-8 minutes. The surgery was completed using the same aiming arms and the standard locking option for the patient. It was an impending fracture distally down the shaft of the femur, so nothing was compromised. The patient outcome is unknown. Concomitant devices reported: unknown recon nail (part# unknown, lot# unknown, quantity# 1). This report is for one (1) radiolucent recon aiming arm. This is report 1 of 6 for complaint (b)(4).

• Brand Name: RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8945814
• MDR Text Key: 160440786
• Report Number: 2939274-2019-60208
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.010.482
• Device Catalogue Number: 03.010.482
• Device Lot Number: T993311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 08/29/2019 Patient Sequence Number: 1