MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC VA-LCP; SCREW, FIXATION,BONE

Model Number	02.118.402
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient age & weight not provided for reporting.The 510k: this report is for unknown screws: locking, lot number are unknown; udi number is unknown.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.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.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 initial open reduction of internal fixation ankle procedure on (b)(6) 2018, unknown quantity of unknown 2.7 mm va locking screws were not locking in few of the distal holes in distal fibular plate.These holes in the plate were kept empty and procedure was completed successfully without any delay.Patient outcome is reported as stable.This complaint involves one devices this report is 1 of 1 for (b)(4).

• Brand Name: VA-LCP
• 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: 7250005
• Report Number: 2939274-2018-50544
• Device Sequence Number: 16738715
• Product Code: HWC
• UDI-Device Identifier: 10886982038821
• UDI-Public: (01)10886982038821(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2018

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: 02.118.402
• Device Catalogue Number: 02118402
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR