MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number	04.005.526S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient date of birth not available for reporting.Date of implant reported only as 2017, exact date is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter telephone not available for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review was completed.Manufacturing location: monument.Manufacturing date: 19-sep-2017.Expiration date: 31-aug-2026.Part #: 04.005.526s, lot#: h441867 (sterile) - 5.0mm ti locking screw w/t25 stardrive 36mm f/im nail - sterile.Quantity 120.Component parts reviewed: part 04.005.526.999 lot: h419907.5.0mm ti screw blank 36mm for ti meet specification.Inspection sheet for whirl thread, vibe, flute final inspection met inspection acceptance criteria.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ 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 patient was implanted with the trochanteric fixation nail advanced (tfna) nail, tfna screw, and 5.0mm locking screw on unknown date in 2017.On unknown date it was revealed the tfna screw had cut through the lateral cortex of the femur as a result of a non-union.The cut through resulted in irritation of soft tissue.Patient was returned to surgery on (b)(6) 2018 where surgeon removed all hardware.Patient was revised to a total hip construct.This report is for one (1) 5.0mm locking screw.This is report 3 of 3 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM 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: 7481015
• Report Number: 2939274-2018-51977
• Device Sequence Number: 334027
• Product Code: HWC
• UDI-Device Identifier: 10886982085955
• UDI-Public: (01)10886982085955
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 04.005.526S
• Device Catalogue Number: 04.005.526S
• Device Lot Number: H441867
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/02/2018
• 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: 73 YR
• Patient Weight: 61