MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 46MM-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	412.217S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2020.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 presented with hip pain three weeks post-operative.On x-ray, implants show a superior cutout of the femoral head.The original date of implantation was (b)(6) 2020.The patient was having her femoral neck system (fns) implants removed and undergoing a hip hemi arthroplasty.The procedure and patient outcomes were unknown.Concomitant devices reported: antirotation screw for femoral neck sys 100mm length - ster (part# 04.168.500s, lot# 3l32061, quantity# 1).5.0mm ti locking scr slf-tpng w/t25 stardrive 46mm-sterile (part# 412.217s, lot# 2l48457, quantity# 1).Bolt for femoral neck system 100mm length-sterile (part# 04.168.300s, lot# 3l31939, quantity# 1).This report is for 1 5.0mm ti locking scr slf-tpng w/t25 stardrive 46mm-sterile.This is report 4 of 4 for (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.H3, h6: a product investigation was conducted.Visual inspection: 5.0mm ti locking scr slf-tpng w/t25 stardrive 46mm-sterile (part.No: 412.217s, lot.No: 2l48457, qty: 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the device looks good without any physical damage except normal wear.Functional test: a complete functional test cannot be performed at cq due to the received condition of the devices.But the screw was inserted and screwed in properly into neck fix plate 1-ho tan (04.168.000/ 5l44120).Dimensional inspection: dimensional inspection of the returned devices was performed at cq.Threaded diameter of the received screw was measured and is within specification as per the relevant drawings.Document/specification review: the relevant drawings were reviewed during the investigation: no design issues or discrepancies were noted during the investigation.Investigation conclusion: the complaint could not be confirmed for 5.0mm ti locking scr slf-tpng w/t25 stardrive 46mm-sterile (part.No: 412.217s, lot.No: 2l48457).A definitive root cause for the reported problem could not be determined.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part: 412.217s, lot: 2l48457, manufacturing site: mezzovico, release to warehouse date: 17.Dec.2018, expiry date: 30.Nov.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 46MM-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: 10480437
• Report Number: 2939274-2020-03928
• Device Sequence Number: 2792933
• Product Code: KTT
• UDI-Device Identifier: 10886982275448
• UDI-Public: (01)10886982275448
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/07/2020

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: 412.217S
• Device Catalogue Number: 412.217S
• Device Lot Number: 2L48457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 09/24/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIROTATION SCREW FOR FEM NECK SYS 100MM LENGTH; BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE; FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 73