MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 36MM-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	412.212S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: 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.Device history lot: part number: 412.212s.Synthes lot number: 2l56179.Manufacturing site: mezzovico.Release to warehouse date: jan 22, 2019.Expiry date: jan.01, 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's related to the reported complaint condition were identified.Non-conformance nr-0113720 was identified and is not relevant to the complaint condition because, two (2) parts were found to be flat.Those parts were scrapped afterwards.Furthermore, the remaining 78 parts were checked to 100% and were found functional as per design intended.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 patient underwent a revision surgery due to displacement of the femoral head from the neck.Initially the patient was implanted with the reported femoral neck system (fns) devices on (b)(6) 2019.During the revision procedure all the fns devices were successfully removed and the patient was then revised to hemi arthroplasty left hip.The 85mm bolt was removed during the initial surgery and replaced with the 90mm bolt as the surgeon felt that the 85mm bolt was initially too short.The 90mm bolt was the item removed during the revision surgery.The procedure as successfully completed without any surgical delay.Patient status was unknown.This report is for one (1) 5.0 mm ti locking scr slf-tpng w/t25 stardrive 36mm-sterile.This is report 4 of 5 (b)(4).Related product complaint : (b)(4).

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 36MM-STERILE
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9641233
• Report Number: 2939274-2020-00451
• Device Sequence Number: 2139732
• Product Code: KTT
• UDI-Device Identifier: 10886982275394
• UDI-Public: (01)10886982275394
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 412.212S
• Device Catalogue Number: 412.212S
• Device Lot Number: 2L56179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/29/2020
• Patient Sequence Number: 1