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

Model Number	04.005.532S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s gender and weight were not provided for reporting.Date of event 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.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, patient underwent implant procedure.Patient was implanted with one (1) unknown nail, one (1) 5mm titanium locking screw 42mm and one (1) 5mm titanium locking screw 56mm.Post-operative on (b)(6) 2018, patient underwent rotational osteotomy of the femur due to bone not having healed and the alignment being off.During the surgery, surgeon removed two screws and implanted two new screws back in the nail.The screws were removed intact, without difficulty, there was no surgical delay and the procedure was completed successfully.Patient outcome was not reported.This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 42mm f/im nail-ster.This is report 2 of 3 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM 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: 7719680
• Report Number: 2939274-2018-53081
• Device Sequence Number: 1107348
• Product Code: HWC
• UDI-Device Identifier: 10886982086013
• UDI-Public: (01)10886982086013
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

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: 04.005.532S
• Device Catalogue Number: 04.005.532S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/25/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention