MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ANTIROTATION SCREW FOR FEMORAL NECK SYS 110MM LENGTH - STER; APPLIANCE,FIXATION,NAIL

Model Number	04.168.510S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s weight was not provided for reporting.Date of event is unknown.Device remained implanted.Explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation.Initial report is synthes sales representative.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 during an orthopaedic procedure on an unknown date, the antirotation screw for femoral neck system did not lock into the femoral neck bolt.In addition, the measuring for the femoral neck bolt measured long.The surgeon went back and re-tightened the antirotation screw.It is unknown if there was a surgical delay.Patient and surgical outcome is unknown.Concomitant device reported: fns bolt (part# unknown, lot# unknown, quantity# unknown).This report is for one (1) antirotation screw for femoral neck sys 110mm length - ster.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
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 110MM LENGTH - STER
• 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: 7801922
• Report Number: 2939274-2018-53407
• Device Sequence Number: 19170224
• Product Code: KTT
• UDI-Device Identifier: 10886982274649
• UDI-Public: (01)10886982274649
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.168.510S
• Device Catalogue Number: 04.168.510S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 08/24/2018
• Patient Sequence Number: 1
• Patient Age: 21 YR