MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 34MM-STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	412.211S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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) 2021, the patient had an ex-plantation of a failed femoral neck system, original date of the surgery was (b)(6) 2020.The patient has a history of substance abuse.No fragmentation was observed besides the split in the bolt for femoral neck system and anti-rotation screw.Concomitant device reported: femoral neck system (part: 04.268.000s; lot:22p9146; quantity: 1).5.0mm locking screws, with t25 stardrive (part:412.211s;lot:4l80139 quantity: 1).5.0mm locking screws, with t25 stardrive (part:412.210s lot# unknown; quantity:1).This report is for one (1) 5.0mm ti locking scr slf-tpng w/t25 stardrive 34mm-sterile.This is report 4 of 5 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: the complaint condition could not be confirmed during photo investigation.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot : part # 412.211s-us.Lot # 4l80139.Manufacturing site: mezzovico.Release to warehouse date: 14jun 2019.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 34MM-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: 12367652
• Report Number: 2939274-2021-04912
• Device Sequence Number: 4407170
• Product Code: KTT
• UDI-Device Identifier: 10886982275387
• UDI-Public: (01)10886982275387
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 412.211S
• Device Catalogue Number: 412.211S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0 TI LCKNG SCR SLF-TPNG T25 SD 34-SILE; ANTIROTATION SCR FEM NECK 90 LNTH -S; BOLT FOR FEMORAL NECK SYS 90 LENGTH-SILE; FEMORAL NECK SYSTEM PL 2 HOLE - STERILE; 5.0 TI LCKNG SCR SLF-TPNG T25 SD 34-SILE; ANTIROTATION SCR FEM NECK 90 LNTH -S; BOLT FOR FEMORAL NECK SYS 90 LENGTH-SILE; FEMORAL NECK SYSTEM PL 2 HOLE - STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR