MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPS-ITE CRKSCRW 5.5X14.7MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
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 (b)(6) 2022, it was reported by a sales representative via email that an ar-1927bcf-3 bio-composite corkscrew anchors broke during insertion.There was not harm to the patient but his caused an hour delay in the procedure.This was discovered during a procedure on (b)(6) 2022.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the broken anchor.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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: 14976703
• Report Number: 1220246-2022-05207
• Device Sequence Number: 20108401
• Product Code: MAI
• UDI-Device Identifier: 00888867023369
• UDI-Public: 00888867023369
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/19/2022

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 Expiration Date: 09/30/2025
• Device Model Number: BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
• Device Catalogue Number: AR-1927BCF-3
• Device Lot Number: 14372567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 07/19/2022
• Date Device Manufactured: 10/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown