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).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a manufacturing record evaluation could not be performed as the lot number could not be determined from the image.The implant(s) was not returned, and the investigation will be completed based on the supplied image.The image(s) was reviewed, and the complaint condition(s) of migration was confirmed as the image(s) provided showed the spiral plate migrated laterally from the nail inside the patient.As the implant(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• 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
• MDR Report Key: 11653046
• MDR Text Key: 245356574
• Report Number: 2939274-2021-01823
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982087461
• UDI-Public: 10886982087461
• Combination Product (y/n): N
• PMA/PMN Number: K033618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: Health Professional
• Device Model Number: 04.013.046
• Device Catalogue Number: 04.013.046
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Patient Sequence Number: 1
• Treatment: UNK - CONSTRUCTS: HINDFOOT ARTHRODESIS NAIL; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR