MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	412.214S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 (b)(6) 2020, the surgeon was converting the patient to total hip arthroplasty.The 5.0 mm locking screw was stripped but was removed successfully.Action taken when the event occurred included screw removal set and a midas rex to remove the stripped screw.There was a surgical delay of five (5) minutes.The procedure was successfully completed.There was no patient consequence.This report involves one (1) 5.0mm ti locking scr slf-tpng w/t25 stardrive 40mm-sterile.This is report 1 of 1 for (b)(4).This complaint, (b)(4), is related to (b)(4).(b)(4) captures the intra-op event of the stripped 5.0 mm locking screw.(b)(4) captures the post-op event of the patient experiencing pain.

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10501191
• Report Number: 2939274-2020-03998
• Device Sequence Number: 3222636
• Product Code: KTT
• UDI-Device Identifier: 10886982275417
• UDI-Public: (01)10886982275417
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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: 412.214S
• Device Catalogue Number: 412.214S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention