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

Model Number	SUTURE ANCHOR, HIP PUSHLOCK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2022
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 hip arthroscopy with labral repair the tip of the anchor broke off while the surgeon tried to insert it.There was no harm for patient, operator or third party reported.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.Visual evaluation found that the eyelet is missing, and shaft of the device is bent.However, the 2.9mm pushlock eyelet was not returned for investigation.During insertion, excessive force may have caused the eyelet to break, and also bent the shaft.The observed condition is undetermined.

• Brand Name: SUTURE ANCHOR, HIP 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: 15570117
• Report Number: 1220246-2022-05593
• Device Sequence Number: 2781275
• Product Code: HWC
• UDI-Device Identifier: 00888867023130
• UDI-Public: 00888867023130
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K061863
• 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): 12/28/2022

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, HIP PUSHLOCK
• Device Catalogue Number: AR-1923PHS
• Device Lot Number: 14937750
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown