MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PL COLLAR 5 H/57; PLATE, FIXATION, BONE

Model Number 241.351

Device Problem Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that on an unknown date, during an unknown procedure, the surgeon commented that the distal fibula plate was too bulky and decided to remove it in exchange for a 1/3 tubular plate on the fibula.While using a 1/3 tubular on the medial side of the tibia, the surgeon could not get the locking mechanism to function, however, it was possible that the locking hole was deformed by putting a previous non-locking screw.There was no surgical delay.The procedure was successfully completed.There were no patient consequences.This report is for (1) lcp one-third tubular pl collar 5 h/57.This is report 2 of 3 for (b)(4).

• Brand Name: LCP ONE-THIRD TUBULAR PL COLLAR 5 H/57
• 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: 12719732
• MDR Text Key: 279113062
• Report Number: 2939274-2021-06377
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982166852
• UDI-Public: 10886982166852
• Combination Product (y/n): N
• PMA/PMN Number: K011335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 241.351
• Device Catalogue Number: 241.351
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2.7/3.5 LCP LATERAL DSTL FIB PL 4H/RT/86; 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 32
• Patient Weight: 113