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

Model Number	04.005.530S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/07/2020
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.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 a femur fracture procedure using retrograde femoral nail.During the procedure, an incorrect protection sleeve was used and the screws missed the nail leaving a small hole in the nail.The screws were removed.The surgeon inserted the correct protection sleeve, drilled and inserted screws.There was a five (5) minute surgical delay.The procedure outcome is unknown.There was no patient harm.This complaint involves four (4) devices.This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 40mm f/im nail-ster.This is report 3 of 3 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: h3, h4, h6: the complaint device are not available to return for investigation.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: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10171983
• Report Number: 2939274-2020-02894
• Device Sequence Number: 1762510
• Product Code: HWC
• UDI-Device Identifier: 10886982085993
• UDI-Public: (01)10886982085993
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 06/07/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.005.530S
• Device Catalogue Number: 04.005.530S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS; 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM; 5.0MM TI LOCKING SCREW W/T25 STRDRV 58MM F/IM NAIL
• Outcome Attributed to Adverse Event: Required Intervention