MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERILE; APPLIANCE, FIXATION, NAIL

Model Number	04.168.485S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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) 2019, the patient presented in the clinic due to post-operative pain on the hip.An x-ray showed non-union with broken anti-rotation screw and potentially the bolt is broken.The distal locking screws and plate appear to be intact.Initially, the patient underwent an open reduction internal fixation (orif) of the right femur on an unknown date.At this point, no revision surgery has been scheduled.Concomitant device reported: titanium locking compression plate (lcp) proximal lateral tibia (part # 422.226, lot # 2192572, quantity 1).Femoral neck system plate (part # 04.168.000s, lot # unknown, quantity 1).Titanium locking screw (part # 412.213s, lot # unknown, quantity 1) and unknown locking screws (part # unknown, lot # unknown, quantity unknown).This report is for one (1) anti-rotation screw for femoral neck sys 85mm length - sterile.This is report 1 of 2 for (b)(4).

• Brand Name: ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM 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: 9135267
• Report Number: 2939274-2019-61043
• Device Sequence Number: 16788363
• Product Code: KTT
• UDI-Device Identifier: 10886982274595
• UDI-Public: (01)10886982274595
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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: 04.168.485S
• Device Catalogue Number: 04.168.485S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 88