MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.005.530S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2020, the patient underwent revision surgery due to adverse events.On (b)(6) 2020, the patient presented to the surgeon with pain and was found to have a nonunion of the fracture site and mechanical fatigue of the locking screw and a titanium cannulated proximal femoral nailing system (tfna) long nail.The tfna helical blade, nail, and the lateral segment of the locking screw were removed.No attempt was made to retrieve the medial segment of the locking screw.The non-union site was debrided and a cannulated trochanteric fixation nail, helical blade, and locking screw were inserted.The date of the original implant was on (b)(6) 2019, for a proximal femur fracture.The procedure outcome is unknown.There was a patient consequence.Concomitant device reported: 12mm/130 deg ti cann tfna 380mm/left-sterile (part#: 04.037.259s, lot#: h218356.Quantity 1).Tfna fenestrated helical blade 100mm - sterile (part#: 04.038.400s, lot#: unknown.Quantity 1).This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 40mm f/im nail-ster this is report 2 of 2 for (b)(4).
Event or Problem Description
Concomitant devices: 5.0mm ti locking screw 40mm (part: 04.005.530s, lot: h218356, quantity: 1), tfna fenestrated helical blade (part: 04.038.400s, lot: h797967, quantity: 1).
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.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9897975
• Report Number: 2939274-2020-01594
• Device Sequence Number: 2818467
• Product Code: HSB
• UDI-Device Identifier: 10886982085993
• UDI-Public: (01)10886982085993
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 04.005.530S
• Device Catalogue Number: 04.005.530S
• Device Lot Number: H218356
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention