MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER ROD, FIXATION, INTRAMEDULLARY

Model Number 456.476S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown. Additional procode: hwc. Device malfunctioned intra-operatively and was not implanted / explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter email address is unavailable. The investigation could not be completed; no conclusion could be drawn, as no product was received. A device history records review has been requested. (b)(4). 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 the patient underwent hip surgery on (b)(6) 2018. During the procedure, the helical blade did not pass through the trochanteric fixation nail system (tfn) on back table when testing the nail prior to insertion into patient. This resulted in the use of the tfn-advanced proximal femoral nailing system (tfna) intraoperatively. Postoperatively, the surgery team came to realize that out of the sterile packaging, the set screw was engaged too far into the nail, engaging the locking mechanism in the nail and preventing the helical blade from passing. The set screw needed to be dialed back a few turns in order the for the blade to pass. It is unknown if there was surgical delay. Patient outcome is unknown. Concomitant devices: tfn helical blade (part: unknown, lot: unknown, quantity: 1), trauma screw (part: unknown, lot: unknown, quantity: 1). This report is for a 12mm/130 deg titanium (ti) cann troch fixation nail 360mm/right-ster. This is report 1 of 1 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7626773
• MDR Text Key: 111938485
• Report Number: 2939274-2018-52580
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011857
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 456.476S
• Device Catalogue Number: 456.476S
• Device Lot Number: 9850781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2015
• 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: 06/21/2018 Patient Sequence Number: 1