MAUDE Adverse Event Report: ARTHREX, INC. H/W INTERNALBRACE LGMNT AUGMNT REPR KIT; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number H/W INTERNALBRACE LGMNT AUGMNT REPR KIT

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 09/23/2021, it was reported by a sales representative via phone that when the surgeon was drilling using the ar-8978-cp implant system, he noticed that the kit only contained qty.2 on the 3.5 drill bits.The surgeon used the 3.5 drill bit and when inserted the implant onto the patient, the implant pulled out of the bone as it had no interference.This was discovered during use in a ucl internal brace procedure on (b)(6) 2021.The case was completed by using an ar-1941psv, 3.9 mm knotless corkscrew.

• Brand Name: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12616680
• MDR Text Key: 276155325
• Report Number: 1220246-2021-03787
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867286801
• UDI-Public: 00888867286801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Device Catalogue Number: AR-8978-CP
• Device Lot Number: 13077046
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other