MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.524
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported that on an unknown date, a nonunion from a previous surgery in the femoral shaft/proximal femur was discovered.The surgeon removed a tfna device, used the ria to collect bone graft, and then inserted a 95 degree blade plate to correct the nonunion.No further information was provided.This report is for one (1) 5.0 ti lckng scr t25 sd 34 for im nails.This is report 4 of 5 for (b)(4).
Additional 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: h6: the device lot number is unknown, therefore a device history record (dhr) review could not be performed.If more information become available, the record will be re-assessed.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the received photo.The images were reviewed, and the complaint condition is not confirmed.After review of the x-rays provided, it is shown that a set of one tfna nail, one tfna blade, 2 locking screws screws and one end cap are present implanted on the patient in the femoral shaft/proximal femur area.The implants do not appear to have any defect or malfunction that could contribute to the nonunion condition or the adverse events reported by the patient.No other issues were found on the device.This complaint is not confirmed as a photo inspection does not show malfunction of the complaint device.A manufacturing record evaluation cannot be performed due to lack of lot number.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and 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: 5.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS
• Common Device Name: SCREW, FIXATION, BONE
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13253447
• Report Number: 2939274-2022-00165
• Device Sequence Number: 14570054
• Product Code: HWC
• UDI-Device Identifier: 10886982085924
• UDI-Public: (01)10886982085924
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.005.524
• Device Catalogue Number: 04.005.524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10/125 DEG TI CANN TFNA 440/RIGHT - SILE; 5.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS; TFNA FENESTRATED HELICAL BLADE 105MM; UNK - END CAPS: TFNA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male