MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS; SCREW,FIXATION,BONE

Model Number	04.005.532
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of event is unknown.Date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.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, patient underwent initial surgery for the insertion of a tibial nail.Post-operative, patient had bone infection and non-union.A hardware removal and revision surgery was performed on (b)(6) 2018.An 11 mm ti cannulated tibial nail and four (4) 5.0 mm ti locking screws were removed successfully and all intact.The revision surgery entailed the insertion of an antibiotic nail until the bone infection clears and will eventually be replaced with another tibial nail.There were no surgical delays, surgery was completed successfully and the patient outcome was reported as stable.This report is for one (1) 5.0 mm ti locking screw w/t25 stardrive 42 mm for im nails.This is report 4 of 5 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS
• 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: 7402424
• Report Number: 2939274-2018-51501
• Device Sequence Number: 723159
• Product Code: HWC
• UDI-Device Identifier: 10886982086006
• UDI-Public: (01)10886982086006(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

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 Model Number: 04.005.532
• Device Catalogue Number: 04.005.532
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/06/2018
• 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: 54 YR
• Patient Weight: 108