MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW COUPLING SCREW ROD, FIXATION, INTRAMEDULLARY

Model Number 03.037.026

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is synthes sales consultant. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 on (b)(6) 2018 during a hip surgery, the cannulation at the tip of the connection bolt for trochanteric femoral nail advanced (tfna) helical blade/ screw coupling screw insertion has a bent tip that does not allow the 3. 2 guide wire to pass through. It is unknown if there was surgical delay. Procedure outcome and patient status unknown. Concomitant devices reported: 3. 2 guide wire (part #: unknown, lot#: unknown, quantity#: unknown). This report is for one (1) helical blade/screw coupling screw. This is report 1 of 1 for complaint (b)(4).

• Brand Name: HELICAL BLADE/SCREW COUPLING SCREW
• 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): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8122355
• MDR Text Key: 129039350
• Report Number: 2939274-2018-55221
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.037.026
• Device Catalogue Number: 03.037.026
• Device Lot Number: 9956792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown