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

Model Number	SUTURE ANCHOR, PEEK PUSHLOCK SP
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a labrum refixation surgery, the push-lock anchor came loose from the drill channel during insertion and had to be removed from the shoulder without sutures.After removal, it was noted that the anchor body was deformed.Per complaint reporter 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
Complaint allegation is confirmed.Visual inspection of the eyelet of the suture anchor, biocomposite pushlock® sp 4.5 x 28 mm, was bent, and the tip of the peek screw.Functional testing was not performed due to the damage to the device.Per dfu-0087-eo - g.Precautions - 3.Make sure to use the recommended drill bit or punch to create the bone socket.4.Pushlock and swivelock suture anchors only: during anchor insertion, ensure that the angle of anchor insertion is coaxial to that of the previously prepared bone socket.5.Pushlock and swivelock suture anchors only: insert the driver into the bone socket until the anchor body makes contact with the bone.Preview and adjust suture tension, if necessary.Tension will not increase during final advancement of the anchor body.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed.-visual inspection of the peek screw of the suture anchor, biocomposite pushlock® sp 4.5 x 28 mm, loose in the shaft and not fully seated.The eyelet and anchor were observed to be bent at the tips, and the anchor's threads were warped.The eyelet was returned, detached from the device.-functional testing was not performed due to the damage to the device.Per dfu-0087-eo - g.Precautions - 3.Make sure to use the recommended drill bit or punch to create the bone socket.4.Pushlock and swivelock suture anchors only: during anchor insertion, ensure that the angle of anchor insertion is coaxial to that of the previously prepared bone socket.5.Pushlock and swivelock suture anchors only: insert the driver into the bone socket until the anchor body makes contact with the bone.Preview and adjust suture tension, if necessary.Tension will not increase during final advancement of the anchor body.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SUTURE ANCHOR, PEEK PUSHLOCK SP
• 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: jared engle ; 8009337001
• MDR Report Key: 24066636
• Report Number: 1220246-2026-00196
• Device Sequence Number: 15797922
• Product Code: MBI
• UDI-Device Identifier: 00888867022973
• UDI-Public: (01)00888867022973(11)250101(17)291231(10)4240152234
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K251145
• 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,Followup
• Report Date (Section B): 04/22/2026

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: SUTURE ANCHOR, PEEK PUSHLOCK SP
• Device Catalogue Number: AR-1922PSM
• Device Lot Number: 4240152234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Distributor Facility Aware Date: 10/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 03/03/2026; 04/21/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/06/2026; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown