MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPOSITE CRKSCRW 5.5X14.7MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMPOSITE CRKSCRW 5.5X14.7MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/7/2023, it was reported by a sales representative via email that an ar-1927bcf-3 5.5 mm biocomposite corkscrew ft tripleplay distal tip broke during insertion.As the surgeon twisted the anchor to deploy it, a sound was heard and immediately twisted back to remove the anchor.Most of the anchor was intact except for the distal tip, which had broken off in one piece and stayed in the bone with the sutures still threaded through it.The surgeon tried to pull on the sutures to remove it, but it wouldn't pull out.The surgeon cut the sutures flush to the cortex, and the broken tip came out later in the procedure while punching for the next anchor.The loose fragments were retrieved from the joint.The case was completed using a new anchor with a different lot number, and the patient was not harmed.This was discovered during an rcr procedure on (b)(6) 2023.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely causes of the reported failure are improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: BIO-COMPOSITE CRKSCRW 5.5X14.7MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18444966
• Report Number: 1220246-2024-00091
• Device Sequence Number: 8145369
• Product Code: MAI
• UDI-Device Identifier: 00888867023369
• UDI-Public: 00888867023369
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• 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,Followup
• Report Date (Section B): 10/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BIO-COMPOSITE CRKSCRW 5.5X14.7MM
• Device Catalogue Number: AR-1927BCF-3
• Device Lot Number: 15048299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown