MAUDE Adverse Event Report: ARTHREX INC. IMPLANT SYSTEM HAND/WRIST INTERNALBRACE LIGAMENT AUGMENTATION REPAIR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number AR-8978-CP

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2021

Event Type  malfunction  

Event Description

Arthrex internal brace kit (ar-8978-cp) was brought in for a surgical procedure.Kit had two 3.5mm drill bits instead of one 3.0mm and one 3.5mm.Surgeon drilled a hole larger than intended with the 3.5mm drill bit resulting in the use of a larger anchor than anticipated.Procedure was completed and the outcome was not affected by the packaging error.Fda safety report id# (b)(4).

• Brand Name: IMPLANT SYSTEM HAND/WRIST INTERNALBRACE LIGAMENT AUGMENTATION REPAIR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.
• MDR Report Key: 12540050
• MDR Text Key: 273775364
• Report Number: MW5104223
• Device Sequence Number: 1
• Product Code: MBI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-8978-CP
• Device Catalogue Number: AR-8978-CP
• Device Lot Number: 13077046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 54