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

Model Number SUTURE ANCHOR, PEEK PUSHLOCK

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 01/17/2023

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 309647062
• Report Number: 1220246-2023-06295
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867023147
• UDI-Public: 00888867023147
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K061863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other