MAUDE Adverse Event Report: ARTHREX, INC. BC, CORKSCREW FT, TRI-PLAY, 4.75MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BC, CORKSCREW FT, TRI-PLAY, 4.75MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
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) 2021 it was reported by a sales representative via email that an ar-1927bcf-475 corkscrew's handle sheared off at the proximal edge of the implant causing sharp edged that ended up cutting the sutures.This was discovered during a subscapularis repair on (b)(6) 2021.Surgeon used an easy out to retrieve most of the metal and to pull out the anchor.By using another anchor, surgeon was able to complete case successfully with no patient affected.Additional info requested.Additional info received 09/16/2021: device broke upon the final turn of insertion and the broken sharp edged cute into the sutures.Device will not be retuned as i was discarded by facility.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the tip of the shaft of the device had broken off.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.

• Brand Name: BC, CORKSCREW FT, TRI-PLAY, 4.75MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12571546
• Report Number: 1220246-2021-03735
• Device Sequence Number: 19729520
• Product Code: MAI
• UDI-Device Identifier: 00888867238541
• UDI-Public: 00888867238541
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K173788
• 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): 10/05/2021

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: 08/31/2024
• Device Model Number: BC, CORKSCREW FT, TRI-PLAY, 4.75MM
• Device Catalogue Number: AR-1927BCF-475
• Device Lot Number: 11791487
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/05/2021
• Patient Sequence Number: 1