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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional patient identifier: (b)(6).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.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 on (b)(6) 2021 the patient underwent hardware removal procedure due to distal femur nonunion.The removal of an ex rafn from the femur was done and patient was revised with a synthes retrograde advanced nail.The procedure was successfully completed.This report is for one (1) ti spiral blade 70mm for ti retrograde femoral nails-ex.This is report 2 of 5 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.H10 additional narrative: investigation summary: the complaint device ti spiral bld 70 for ti retro fem nl-ex (product code: 04.013.046, lot number: unknown) was not received for investigation.A photo investigation was performed.The image was reviewed, and the complaint cannot be confirmed.Based on the x-ray evidence provided, it can be observed that the patient had a distal femur nonunion.However, it is not possible to confirm a product failure regarding the reported allegations.A manufacturing record evaluation cannot be performed due to lot number being unknown.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.No dhr review was completed since no lot number was supplied via photo or additional information.During the investigation no product design issues or discrepancies were observed (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.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
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13255724
• MDR Text Key: 283817681
• Report Number: 2939274-2022-00174
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982087461
• UDI-Public: (01)10886982087461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 11 TI CANN RETRO/ANTEGRADE FEM NL/380-S; 5.0 TI LCKNG SCR T25 SD 50 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 50 FOR IM NAILS; TI SPIRAL BLD 70 FOR TI RETRO FEM NL-EX
• Patient Outcome(s): Required Intervention
• Patient Sex: Female