MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 50; SCREW, FIXATION, BONE

Model Number	02.211.050
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(6).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.The product was not returned.Based on the information available, it has been determined that no corrective and 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 on (b)(6) 2021, the patient underwent for an open reduction and internal fixation (orif) procedure.A two-hole va-lcp proximal tibia plate system were used.Upon surgery four (4) va locking screws were inserted to the plate.One (1) locking screw was swapped out due to it didn't lock into the plate.The three (3) va locking screws were left in the plate.There was a one-minute surgical delay.Patient outcome was successful.Concomitant devices reported: va-lcp olecr pl 2.7/3.5 le 2ho l90 sst (part# 02.107.302, lot# unknown, quantity# 1); 2.7mm va lck screw slf-tap (part# 02.211.012, lot# unknown, quantity# 1); 2.7mm va lck screw slf-tap (part# 02.211.014, lot# unknown, quantity# 1); 2.7mm va lck screw slf-tap (part# 02.211.048, lot# unknown, quantity# 1).This complaint involves one (1) device.This report is for (1)2.7mm va lck screw slf-tap.This report is 5 of 5 for (b)(4).

• Brand Name: 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 50
• 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: 12214505
• Report Number: 2939274-2021-04236
• Device Sequence Number: 16946352
• Product Code: HRS
• UDI-Device Identifier: 10886982053763
• UDI-Public: (01)10886982053763
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/25/2021

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: 02.211.050
• Device Catalogue Number: 02.211.050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/22/2021
• Patient Sequence Number: 1
• Patient Age: 55 YR