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
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional 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.(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 or Problem Description
It was reported that on (b)(6) 2021 the patient underwent a fusion of her calcaneus, talus, and tibia using a hindfoot arthrodesis nail.During a follow-up appointment, it was discovered that the interlocking spiral blade backed out and needed to be removed.The other screws and nail are not planned were not removed during the revision on (b)(6) 2021.It is possible that the patient was walking on it (against surgeons post op orders) as there was slight radiolucency around the entry point of the nail as if it had been toggling.The sight looked infected.This report is for one (1) ti spiral blade 70mm for ti retrograde femoral nails-ex.This is report 1 of 3 for (b)(4).

• Brand Name: TI SPIRAL BLADE 70MM FOR TI RETROGRADE FEMORAL NAILS-EX
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11880198
• Report Number: 2939274-2021-02562
• Device Sequence Number: 14240280
• Product Code: HSB
• UDI-Device Identifier: 10886982087461
• UDI-Public: 10886982087461
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.013.046
• Device Catalogue Number: 04.013.046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR