MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM BC SWVLK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	DBL LOADED 4.75MM BC SWVLK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
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
It was reported during a shoulder repair procedure, the surgeon inserted the ar-2324bct-2, double loaded swivel lock, as the surgeon gently tighten down the suture the suture broke within the anchor.The anchor was seated and secured, the broke sutures were removed.The surgeon inserted a second ar-2324bct-2, double loaded swivel lock, the anchor was seated secured, as the surgeon lightly pulled the suture coiled up.The broken suture was removed and the case was completed by creating a new tunnel and using a new ar-1927psf-3 to complete the case.No patient harm reported.The case was prolonged a little longer then anticipated.
Additional Manufacturer Narrative
Complaint confirmed, even though the two devices were returned without eyelets and sutures, broken suture strands were returned disassembled from the devices.One of the sealed devices returned was opened and no abnormality was observed with the suture.The cause of the event is undetermined, however a likely cause is user-applied mechanical forces.

• Brand Name: DBL LOADED 4.75MM BC SWVLK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12300350
• Report Number: 1220246-2021-03487
• Device Sequence Number: 5403250
• Product Code: MAI
• UDI-Device Identifier: 00888867251236
• UDI-Public: 00888867251236
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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): 09/15/2021

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: 04/30/2023
• Device Model Number: DBL LOADED 4.75MM BC SWVLK
• Device Catalogue Number: AR-2324BCT-2
• Device Lot Number: 13242383
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other