MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: TUBULAR; PLATE, FIXATION, BONE

Device Problem Device-Device Incompatibility (2919)

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

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Pma/510k: this report is for an unk - plates: tubular/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 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, patient underwent a syndesmosis repair with fibulink.When drilling for placement of a fibulink, the stepped drill bit would not pass through the hole of a one-third tubular plate due to mal-alignment (the set has no way to ensure central alignment of the guide wire).When attempting to get the 4.0mm section of the stepped drill bit to pass through the plate which it was caught on, the drill bit snapped at the junction of the 3.0/4.0 portion of the drill bit, leaving the 3.0mm section of the drill bit lodged in both the fibula and tibia.Screw removal kit opened to bore out broken drill bit.The procedure was completed successfully with a surgical delay of 25 minutes.It was unknown if there were fragments generated.There was no patient consequence reported.Concomitant devices reported: unk - extraction instruments: universal screw removal: trauma (part# unknown, lot# unknown, quantity# 1).This complaint involves four (4) devices.This report is for (1) unk - plates: tubular.This report is 2 of 2 for (b)(4).

• Brand Name: UNK - PLATES: TUBULAR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12217580
• MDR Text Key: 263162636
• Report Number: 2939274-2021-04252
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2021
• 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: FIBULINK® SYNDESMOSIS REPAIR KIT/SS; UNK - DRILL BITS: TRAUMA; UNK - EXTRACT INSTRS: UNIVL SCRW REMOVAL: TRAU.; UNK - GUIDES/SLEEVES/AIMING: GUIDE
• Patient Weight: 113