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

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2021

Event Type  malfunction  

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 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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12214505
• MDR Text Key: 263608181
• Report Number: 2939274-2021-04236
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982053763
• UDI-Public: (01)10886982053763
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 02.211.050
• Device Catalogue Number: 02.211.050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR