MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 42MM-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	412.215S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.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.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 on (b)(6) 2020, the surgeon reported a patient with a new fracture near a plate from the femoral neck system (fns) construct.The initial surgery was conducted on (b)(6) 2020 and was successfully completed.The fns construct appears to be intact without wrapping or any implant fragmentation.Originally the implanted devices were: two (2) titanium locking screw, one (1) femoral neck system plate, one (1) bolt, and one (1) anti-rotation screws.It was unknown if there was a revision or hardware removal.Patient status was unknown.This is report 5 of 5 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.Part: 412.215s, lot: 4l96900, manufacturing site: mezzovico, release to warehouse date: july 8, 2019, expiry date: july 1, 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Reviewing attached picture, only the bone breakage can be confirmed.Furthermore, the reported complaint does not include an allegation of a device malfunction.No damages a the implanted parts could be found.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.

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 42MM-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: 9971654
• Report Number: 2939274-2020-01900
• Device Sequence Number: 19469384
• Product Code: KTT
• UDI-Device Identifier: 10886982275424
• UDI-Public: (01)10886982275424
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 412.215S
• Device Catalogue Number: 412.215S
• Device Lot Number: 4L96900
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 05/07/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 48MM-S; ANTIROTATION SCREW FOR FEMORAL NECK 95MM-S; BOLT FOR FEMORAL NECK SYSTEM 95MM-S; FEMORAL NECK SYSTEM PLATE 2 HOLE-S
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR