MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI SPIRAL BLADE 70MM FOR TI RETROGRADE FEMORAL NAILS-EX ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.013.046

Device Problem Migration (4003)

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. 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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that a revision operation was performed. Six (6) weeks post-op there was a hindfoot spiral blade dismantle, the spiral blade backed out despite the end cap implantation to lock it in place. The ttc construct failed (hindfoot nail with spiral blade) and revision surgery was performed to remove the blade. Skin necrosis appeared caused by the spiral blade head protruding towards the back of the foot. Since the talus screw and proximal calcaneum 6. 0mm screws remained solid, no further steps were needed. Two (2) weeks post-op the patient was allowed by the surgeon to put full weight bearing. Six (6) weeks post-op [(b)(6) 2021)], a clinical follow up was made. The x-rays showed that the spiral blade had backed out. The revision surgery was performed to remove the blade. The nail and all screws remained in place. The surgeon believes it will heal without the blade. Concomitant devices: unknown hindfoot nail (part# unknown; lot# unknown; quantity: 1), unknown screws (part# unknown; lot# unknown; quantity: unknown). This report is for one (1) ti spiral blade 70mm for ti retrograde femoral nails-ex. This is report 1 of 1 for (b)(4).

• Brand Name: TI SPIRAL BLADE 70MM FOR TI RETROGRADE FEMORAL NAILS-EX
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11653046
• MDR Text Key: 245356574
• Report Number: 2939274-2021-01823
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K033618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 04.013.046
• Device Catalogue Number: 04.013.046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/12/2021 Patient Sequence Number: 1