MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7 LCKNG SCREW SLF-TPNG T8 SD REC 16; PLATE, FIXATION, BONE

Model Number 202.216

Device Problem Device-Device Incompatibility (2919)

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

Event Date 10/01/2021

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021 during a procedure, the surgeon found the anterolateral plate was too bulky and not able to lock the screw.The screw appeared to be at a different angle than the nominal angle.Procedure was completed successfully without any surgical delay.No patient consequences.This report is for one (1) 2.7 lckng screw slf-tpng t8 sd rec 16.This is report 3 of 3 for complaint (b)(4).

Manufacturer Narrative

Additional product code: hwc, ktt.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.Product was not returned.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.

• Brand Name: 2.7 LCKNG SCREW SLF-TPNG T8 SD REC 16
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12708044
• MDR Text Key: 282346040
• Report Number: 2939274-2021-06340
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982143990
• UDI-Public: (01)10886982143990
• Combination Product (y/n): N
• PMA/PMN Number: K033995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 202.216
• Device Catalogue Number: 202.216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• 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
• Treatment: 2.7/3.5 VA ANTEROLAT DSTL TIB PL/6 H/RT; 2.7MM LCP(TM) PLATE 8 HOLES/76MM
• Patient Age: 25 YR
• Patient Weight: 77