MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 48MM-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	412.218S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Only event year is known.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient underwent removal of femoral neck system implants due to femoral neck implant varus collapse.The devices were implanted on (b)(6) 2020.The devices were successfully removed.Concomitant devices reported: femoral neck system plate 1 hole ¿ sterile (part number 04.168.000s, lot 6l12276, quantity 1), bolt for femoral neck system 85mm length-sterile (part number 04.168.285s, lot 3l26381, quantity 1), antirotation screw for femoral neck sys 85mm length ¿ sterile (part number 04.168.485s, lot 3l42054, quantity 1).This report involves one (1) 5.0mm ti locking scr slf-tpng w/t25 stardrive 48mm-sterile.This is report 4 of 4 for (b)(4).
Event or Problem Description
It was reported that the patient was revised to a total joint.
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.A device history record (dhr) review was conducted: part: 412.218s.Lot: 3l01223.Manufacturing site: (b)(4).Release to warehouse date: 07.Feb.2019.Expiry date: 31.Dec.2028.A manufacturing record evaluation was performed for the finished device lot number, 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 48MM-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: 10189940
• Report Number: 2939274-2020-02967
• Device Sequence Number: 10990097
• Product Code: KTT
• UDI-Device Identifier: 10886982275455
• UDI-Public: (01)10886982275455
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

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: 412.218S
• Device Catalogue Number: 412.218S
• Device Lot Number: 3L01223
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIROTATION SCREW; BOLT FOR FEMORAL NECK SYSTEM 85MM; FEMORAL NECK SYSTEM PLATE 1 HOLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 72