MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number	04.005.528S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Patient age or date of birth and weight not available for reporting.Date of non-union and device breakage is not known.(b)(4) expiration unknown(10) lot number unknown.Date of implant is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient had previous fracture on an unknown date that was fixed with a synthes retrograde/antegrade femoral nail(rafn) and three (3) locking screws.Two (2) of the distal locking screws are broken distally in the nail, the proximal screw remains intact.The patient underwent a revision of the open reduction of internal fixation (orif) on (b)(6) 2018 to address the nonunion fracture that was still present.The broken screws were removed successfully and the intact screw and nail remained implanted.A synthes variable angle condylar plate and screws was implanted to address the nonunion fracture.Concomitant devices reported: retrograde/antegrade femoral nail (part number unknown, lot number unknown, quantity 1).This report is for one (1) 5.0 mm locking screw.This is report 2 of 2 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM 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: 7287386
• Report Number: 2939274-2018-50717
• Device Sequence Number: 1475377
• Product Code: HWC
• UDI-Device Identifier: 10886982085979
• UDI-Public: (01)10886982085979(17)EXPIRATIONUNKNOWN(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2018

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: 04.005.528S
• Device Catalogue Number: 04.005.528S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/21/2018
• 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