MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT III; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,CRKSCRW FT III
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff repair surgery the upper part of the tip broke off.It was not possible to insert the implant into the sclerotic bone.The partially inserted anchor was successfully removed.It was mentioned that the initial hammering could have lead to the breakage.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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
Complaint is confirmed.Visual evaluation revealed a crack to the rim of the corkscrew and on the threading.The corkscrew assembly is missing the sutures, sp-02-01b and sp-02-01w.In addition, the driver was not returned with the corkscrew.Functional testing could not be performed due to the missing components and the damage to the device.The most likely cause of the reported failure can be attributed to user error due to excessive force used during initial hammering.

• Brand Name: SUTR ANCH,CRKSCRW FT III
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 17489242
• Report Number: 1220246-2023-07466
• Device Sequence Number: 12718259
• Product Code: HWC
• UDI-Device Identifier: 00888867023727
• UDI-Public: 00888867023727
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K061863
• 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): 10/21/2024

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: SUTR ANCH,CRKSCRW FT III
• Device Catalogue Number: AR-1928SF-3
• Device Lot Number: 15082597
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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