MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - GUIDES/SLEEVES/AIMING: AIMING ARM

Device Problems Device-Device Incompatibility (2919); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - guides/sleeves/aiming: aiming arm/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 on that (b)(6) 2021, the patient underwent for a surgery.During the surgery, it was noticed that the outer sleeves were mixed up with the sleeves which did not fit properly into the aiming arm.The surgery was completed successfully with a five (5) minute surgical delay.There was no patient consequence.This complaint involves four (4) devices.This report is for (1)unk - guides/sleeves./aiming: aiming arm.This report is 3 of 4 for (b)(4).

• Brand Name: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM
• Type of Device: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12417861
• MDR Text Key: 273625760
• Report Number: 2939274-2021-05155
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Patient Sequence Number: 1
• Treatment: 10 / TI CANN FRN / GT 360 / LEFT - SILE.; UNK - GUIDES/SLEEVES/AIMING: SLEEVE.; UNK - SCREWS: NAIL PROXIMAL LOCKING.
• Patient Age: 18 YR
• Patient Weight: 59