MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 50MM F/IM NAIL-STER; SCREW,FIXATION,BONE

Model Number	04.005.540S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: implanted unknown date in (b)(6) 2018.Device remained implanted.Explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 in (b)(6) 2018, patient underwent the trochanteric fixation nail advanced (tfna) implant procedure due to a hip fracture.Three (3) months postoperatively, the distal locking screw broke.Patient¿s fracture was healed.Removal of the device has not been scheduled as they are unsure if the screw will need removal.Patient status was not reported.Concomitant device reported: tfna nail (part# unknown, lot# unknown, quantity 1).This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 50mm f/im nail-ster.(b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 50MM 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: 7593535
• Report Number: 2939274-2018-52478
• Device Sequence Number: 1814114
• Product Code: HWC
• UDI-Device Identifier: 10886982086099
• UDI-Public: (01)10886982086099
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

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: 04.005.540S
• Device Catalogue Number: 04.005.540S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR