MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/14/2021
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 that during a surgery it was not possible to implant the devices completely.The devices got stuck and no further tightening of the sutures was possible.No part of the devices broke off.The two devices with the same error remained inside the patient and the surgeon switched the procedure from a knotless to a knotted procedure.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (1934bc).It was not necessary to do a second surgery.Update 22-sep-2021: it was confirmed that it was not possible to perform the final tightening of the affected devices and these were not removed because drilling over them would only have caused more damage to the patient.New tunnels had to be drilled for the knotted anchors.Update 27-sep-2021: it was confirmed that the error occurred during a shoulder (labrum) surgery.After the sutures got stuck, they were cut from the anchors and removed.The anchor bodies remained fully implanted inside the patient.
Additional Manufacturer Narrative
Complaint could not be confirmed, since the complaint devices were not returned for evaluation.Visual evaluation on the seal devices did not showed any abnormalities.

• Brand Name: SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 12576867
• Report Number: 1220246-2021-03750
• Device Sequence Number: 3687626
• Product Code: MAI
• UDI-Device Identifier: 00888867282421
• UDI-Public: 00888867282421
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140855
• 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): 11/09/2021

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: 02/28/2026
• Device Model Number: SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
• Device Catalogue Number: AR-1938PS-1
• Device Lot Number: 12942888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 11/09/2021
• Date Device Manufactured: 03/19/2021
• 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