MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 VA LCKNG SCR SLF-TPNG/SD/42; SCREW, FIXATION, BONE

Model Number	02.127.142
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.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 will be filed as appropriate.
Event or Problem Description
It was reported that while attempting to insert a 3.5 va locking screw into a va locking hole, the screw would not lock into the plate.A 3.5 cortex screw was placed in the hole and the surgery was completed successfully without any surgical delay.Additionally, it was reported that a periarticular reduction forceps was difficult to open.However, it opened freely once it was wet with irrigation.It was believed to have bioburden.The forceps remained stiff postoperatively after washing.This report is for the locking screw.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 3.5 VA LCKNG SCR SLF-TPNG/SD/42
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14171775
• Report Number: 2939274-2022-01442
• Device Sequence Number: 12197988
• Product Code: HWC
• UDI-Device Identifier: 10886982043252
• UDI-Public: 10886982043252
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 02.127.142
• Device Catalogue Number: 02.127.142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5 VA PROX TIB PL SMALL BEND/4H/87/LFT; PERIARTIC-REDUCT-FORCEPS MEDIUM; UNK - SCREWS: 3.5 MM CORTEX
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 74 KG