MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH PEEK S-TAK KNOTLESS HIP USE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH PEEK S-TAK KNOTLESS HIP USE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
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.
Event or Problem Description
It was reported that during a hip labral suturing procedure five devices broke during the insertion into the bone.All broken pieces were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.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 confirmed.Two unpackaged peek implants and associated suture constructs from ar-1938phs devices were received for investigation.Visual inspection identified that one implant broke between the third and fourth thread, while the second broke between the fourth and fifth thread of the peek implant.Fraying was visible at the proximal ends of the remainders of both suture constructs.The method used to prepare the bone was not recorded.It was identified that the surgeon did not notice that the bone was harder than normal.The root cause of the event remains undetermined.Potential most likely causes can be contributed to improper bone preparation and user applied mechanical forces to the suturetaks during insertion.Without return of the suturetak inserters, no further analysis can be conducted.

• Brand Name: SUTR ANCH PEEK S-TAK KNOTLESS HIP USE
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11647664
• Report Number: 1220246-2021-02874
• Device Sequence Number: 3832886
• Product Code: MBI
• UDI-Device Identifier: 00888867097216
• UDI-Public: 00888867097216
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K120555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: SUTR ANCH PEEK S-TAK KNOTLESS HIP USE
• Device Catalogue Number: AR-1938PHS
• Device Lot Number: 10435949
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/17/2021
• Patient Sequence Number: 1