MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.3MM CANNULATED SCREW FULLY THREADED/95MM; SCREW, FIXATION, BONE

Model Number	209.695
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was reportedly not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a hardware removal and revision procedure on (b)(6) 2018 one (1) 7.3/95 mm cannulated screw bent while the surgeon was inserted it into the femoral neck as a prophylactic measure.Reportedly, the surgeon felt the device malfunction was related to the patient¿s dense cortical bone tissue.The damaged screw was not removed.No harm was reported to the patient.No surgical delay was reported.The procedure was successfully completed.Patient outcome was reported unknown.Concomitant devices reported: washer 13.0mm (part 219.99, lot unknown, quantity 1).This report is to capture the bent screw.The need for the hardware removal and revision procedure is captured in related complaint (b)(4).This is report 1 of 1 for (b)(4).

• Brand Name: 7.3MM CANNULATED SCREW FULLY THREADED/95MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7711802
• Report Number: 2939274-2018-53028
• Device Sequence Number: 921095
• Product Code: HWC
• UDI-Device Identifier: 10886982150868
• UDI-Public: (01)10886982150868
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K962011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: 209.695
• Device Catalogue Number: 209.695
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/23/2018
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 78