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

Model Number	SUTURE ANCHOR, PEEK PUSHLOCK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
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 stabilization surgery 2 devices (ar- 1923ps) with same lot number: (14604052) were used.When putting labral tape through the eyelet, it was bending the metal tip and the eyelets snapped off.All broken parts 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 devices with the same part number but different lot numbers.It was not necessary to switch the surgical technique.
Additional Manufacturer Narrative
The complaint is not confirmed.(18) packaged ar-1923ps devices were returned for evaluation.The (2) complaint-involved devices were not returned.Visual inspection noted no issues with the returned devices.All packaging material was sealed, and contained all components assembled correctly.(3) devices were opened for functional testing, and all worked as intended: the eyelets and anchors were securely attached and could not be snapped off without the use of excessive force.A potential cause for the alleged failure could be attributed to inadequate technique when inserting the implant resulting in excessive forces detaching the eyelet from the inserter.However, without receipt of the devices involved in the complaint allegation, the failure cannot be verified, and no cause can be determined.No problems were found with the returned devices.

• 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: 15362382
• Report Number: 1220246-2022-05445
• Device Sequence Number: 14924817
• Product Code: HWC
• UDI-Device Identifier: 00888867023147
• UDI-Public: 00888867023147
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K061863
• 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
• Report Date (Section B): 11/18/2022

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
• Device Catalogue Number: AR-1923PS
• Device Lot Number: 14604052
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown