MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM CANNULATED VA LOCKING SCREW/80MM; SCREW, FIXATION, BONE

Model Number	02.231.680
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: jdp and hrs.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.Product was not returned.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.
Event or Problem Description
It was reported that on (b)(6) 2019, the surgeon noted that the cannulated variable locking screw did not lock into distal hole and the surgeon also mentioned it may have stripped the threads on the variable angle- locking condylar plate during screw insertion.Fragments were removed easily without additional intervention.There was no surgical delay and no patient consequence.The procedure was successfully completed.This report is for a cannulated variable locking screw.This is report 1 of 2 for (b)(4).

• Brand Name: 5.0MM CANNULATED VA LOCKING SCREW/80MM
• 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: 8374731
• Report Number: 2939274-2019-56699
• Device Sequence Number: 1606669
• Product Code: HWC
• UDI-Device Identifier: 10886982062918
• UDI-Public: (01)10886982062918
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• 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): 02/02/2019

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: 02.231.680
• Device Catalogue Number: 02.231.680
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2019
• Initial Report FDA Received Date: 02/27/2019
• Patient Sequence Number: 1
• Patient Age: 59 YR