MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR 2.4MM HIP PEEK PUSHLOCK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	SUTURE ANCHOR 2.4MM HIP PEEK PUSHLOCK
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
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 device is reported to remain in the patient.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 an hip arthroscopy surgery the arthrex pushlock ar-2924phs was used.During the procedure the first anchor worked normal.The second anchor pulled out easily used with suturetape.The surgeon was not able to retrieve the anchor body and it will remain inside the patient.The surgery was completed successfully with an device from another manufacturer.No further information received at the moment.Further questions will be asked.Update 19-dec-2019: the hospital discarded the driver after surgery.According to the customer the anchor was located inside the hip joint but was unable to be retrieved.According to the surgeon there are no known consequences for the patient at this stage.

• Brand Name: SUTURE ANCHOR 2.4MM HIP PEEK PUSHLOCK
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9568900
• Report Number: 1220246-2020-01552
• Device Sequence Number: 16677541
• Product Code: MBI
• UDI-Device Identifier: 00888867239111
• UDI-Public: 00888867239111
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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 Model Number: SUTURE ANCHOR 2.4MM HIP PEEK PUSHLOCK
• Device Catalogue Number: AR-2924PHS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other