MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERILE; APPLIANCE, FIXATION, NAIL

Model Number	04.168.495S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2019, the bolt for femoral neck system-sterile, femoral neck system plate-sterile, antirotation screw for femoral neck system-sterile & titanium locking screw self-tapping stardrive-sterile were removed due to device cut of femoral head and was revised to a total hip arthroplasty.The femoral neck system (fns) was implanted on (b)(6) 2019, without complications.Patient status is unknown.Concomitant devices reported: femoral neck system plate 1 hole - sterile (part # 04.168.000s, lot # l885836, quantity # 1), 5.0mm ti locking scr slf-tpng w/t25 stardrive 46mm-sterile (part # 412.217s, lot # l896483, quantity # 1).This is report 2 of 2 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.Device history lot, part: 04.168.495s, lot: 2l19460, manufacturing site: grenchen, release to warehouse date: 24.Nov.2018, expiry date: 30.Nov.2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.05/24/2019: updated event description: it was reported that on (b)(6) 2019, the bolt for femoral neck system-sterile, femoral neck system plate-sterile, antirotation screw for femoral neck system-sterile & titanium locking screw self-tapping stardrive-sterile were removed due to device cut of femoral head and was revised to a total hip arthroplasty.The femoral neck system (fns) was implanted on (b)(6) 2019, without complications.Patient status is unknown.Concomitant devices reported: femoral neck system plate 1 hole - sterile (part # 04.168.000s, lot # l885836, quantity # 1) & 5.0mm ti locking scr slf-tpng w/t25 stardrive 46mm-sterile (part # 412.217s, lot # l896483, quantity # 1).This complaint involves two (2) devices.Investigation flow: device interaction/functional.Visual inspection: the antirotation screw for construct length was received at the us cq.The screw was notably scrapped, with most of its blue outer coating gone expect for recessed areas like in between the threads.The drive recess was worn and dented in.The internal threading was stripped at the opening.The upper external threading was observed to be stripped and deformed.The lower external threading was not stripped but did present with some wear.No other issues could be identified with the returned portions of the device.Functional test: a functional test was performed to test the interaction of the screw with the received associated bolt and plate.The antirotation screw was able to screw into the bolt and prevent the plate from sliding off of the bolt.When hand tightened, the screw is able to wobble slightly.Upon closer inspection, the threading of the bolt was in good condition, but the screw¿s threads were stripped.The complaint can not be replicated with the returned devices.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: drawing(s) reviewed: (current & manufactured revisions) antirotation screw for construct length xx femoral neck system; se-493962.Device history: the received device was manufactured at the grenchen site on 24 november 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint was confirmed for the antirotation screw.The screw was observed to be scrapped and scratched, with deformities and stripping on its drive recess, internal threads, and external threads.While the exact complaint could not be replicated, the screw was observed to wobble when screwed into the associated bolt.Such movement could contribute to migration when put under the varying loads of a walk cycle.There was no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it was possible that the device encountered unintended forces.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.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.
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.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: ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - 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: 8667550
• Report Number: 2939274-2019-58444
• Device Sequence Number: 2169523
• Product Code: KTT
• UDI-Device Identifier: 10886982274618
• UDI-Public: (01)10886982274618
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2019

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: 04.168.495S
• Device Catalogue Number: 04.168.495S
• Device Lot Number: 2L19460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 06/19/2019; 06/26/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/25/2019; 06/26/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMORAL NECK SYSTEM PLATE 1 HOLE-S; TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE-S; FEMORAL NECK SYSTEM PLATE 1 HOLE-S; TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE-S
• Outcome Attributed to Adverse Event: Required Intervention