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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
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 01/16/2024, it was reported by an arthrex subsidiary employee via email that an ar-1927bcf-3 5.5 mm biocomposite corkscrew ft tripleplay anchor broke during insertion.The case was completed using another ar-1927bcf-3 5.5 mm biocomposite corkscrew ft tripleplay.This was discovered during a procedure on (b)(6) 2024.
Event or Problem Description
Additional information received on 1/28/2024: this was discovered during a arcr procedure on (b)(6) 2024.The broken fragments were removed from the patient.There was a slight delay with no additional anesthesia administered.There were no reports of negative effects on the patient due to the anchor breakage.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h6.Complaint allegation is confirmed.One unpackaged, 5.5 mm biocomposite corkscrew®, ar-1927bcf-3, batch 15133272, was received for investigation.Visual evaluation confirms that the anchor is detached from the device and is broken.Functional testing couldn't be performed due to the damage of the device.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical force.As well as improper bone preparation.

• 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: 18594707
• Report Number: 1220246-2024-00575
• Device Sequence Number: 6726198
• Product Code: MAI
• UDI-Device Identifier: 00888867023369
• UDI-Public: 00888867023369
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 15133272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• 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