MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 60; PLATE,FIXATION,BONE

Model Number	02.211.060
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: additional product code: hwc.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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 that (b)(6) 2021, the patient underwent for a surgery.During the surgery, the va locking screw would not lock into plate hole.The procedure was completed successfully without surgical delay.Patient outcome was unknown.Concomitant device reported: unknown screwdriver (part# unknown; lot# unknown; quantity: 1).This complaint involves two(2) devices.This report is for (1) 2.7 va lckng scr slf-tpng t8 sd rec 60.This report is 2 of 2 for (b)(4).

• Brand Name: 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 60
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12421635
• Report Number: 2939274-2021-05167
• Device Sequence Number: 3528034
• Product Code: HRS
• UDI-Device Identifier: 10886982053817
• UDI-Public: (01)10886982053817
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: 02.211.060
• Device Catalogue Number: 02.211.060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/03/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7/3.5 VA-LCP OLECRANON PL 4H/RT/116; UNK - SCREWDRIVERS: SHAFTS
• Patient Age: 59 YR