MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK PUSHLOCK; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, PEEK PUSHLOCK
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
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 that during a shoulder arthroscopy the tip of multiple anchors kept breaking where the tape was inserted.Due to this failure the planned surgery had to be aborted and an additional surgery will be scheduled.
Additional Manufacturer Narrative
Complaint is not confirmed.Visual evaluation noted that the device is missing the eyelet and anchor.However, the broken pieces were not returned for investigation.No problem found.

• Brand Name: SUTURE ANCHOR, PEEK PUSHLOCK
• Common Device Name: SCREW, FIXATION, BONE
• 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: 16385199
• Report Number: 1220246-2023-06295
• Device Sequence Number: 5694208
• Product Code: HWC
• UDI-Device Identifier: 00888867023147
• UDI-Public: 00888867023147
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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 Model Number: SUTURE ANCHOR, PEEK PUSHLOCK
• Device Catalogue Number: AR-1923PS
• Device Lot Number: 14999334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown