MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD,FIXATION,INTRAMEDULLARY

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient information is not available for reporting. Date of postoperative blade cut out is unknown. This report is for one (1) unknown tfna helical blade. Part and lot numbers are unknown. Without the specific part and lot number, the udi is not available. Implanted about three (3) months prior to revision surgery. Date of explant is unknown. Complainant device is not expected to be returned for manufacturer review/investigation. (510k): unknown, as specific part and lot numbers for blade not provided. (b)(4). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 a patient underwent an unknown procedure about three (3) months ago involving a trochanteric femoral nail - advance (tfna) of the femoral head. A tfna blade cut out of the femoral head post-operatively. This was remedied by removing the blade and replaced with a tfna lag screw. No device issues were reported regarding the revision surgery nor patient harm. Concomitant device reported: tfna nail (part # unknown, lot # unknown, quantity 1). This report is for one (1) unknown tfna helical blade. (b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7190342
• MDR Text Key: 97307336
• Report Number: 2939274-2018-50259
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 01/15/2018 Patient Sequence Number: 1