MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 74MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number	04.005.564S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 on an unknown date, two locking screws of the retrograde/antegrade femoral nail (rafn) nail were broken.It is unknown how the issue was discovered.There was no patient consequence reported.Concomitant devices reported: rafn nail (part # unknown, lot # unknown, quantity 1), screws (part # unknown, lot # unknown, quantity unknown); 5.0mm ti locking screw w/t25 stardrive 74mm f/im nail-ster (part # 04.005.564s, lot # unknown, quantity 1).This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 74mm f/im nail-ster.This is report 1 of 2 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 74MM 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: 10478252
• Report Number: 2939274-2020-03903
• Device Sequence Number: 16788766
• Product Code: HWC
• UDI-Device Identifier: 10886982086334
• UDI-Public: (01)10886982086334
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: 04.005.564S
• Device Catalogue Number: 04.005.564S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention