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
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12616680
• Report Number: 1220246-2021-03787
• Device Sequence Number: 3473388
• Product Code: MBI
• UDI-Device Identifier: 00888867286801
• UDI-Public: 00888867286801
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K150648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other