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

Model Number	SUTURE ANCHOR, PEEK PUSHLOCK SP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2020
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 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 rotator cuff repair, the surgeon was malleting in the pushlock.On correct removal, the tip of the anchor stayed in the bone but the screw came out.Surgeon was not able to remove the tip of the anchor, it will remain inside of the patient.Two ar-1922psm-1 w / batches 10625897 and 10401450 were used during the surgery.It's not possible to determine which batch failed during the surgery.The surgery was completed successfully with a 4.75 sp swivelock.No further information has been made available.
Additional Manufacturer Narrative
One unpackaged ar-1922psm-1 drive assembly was received for investigation.The anchor associated with the ar-1922psm-1 that allegedly pulled out of the bone was not returned for analysis.No abnormalities were identified when inspecting the drive assembly.As such, the complaint cannot be confirmed.It was noted that the method used to prepare the bone, as well as the bone quality encountered, were not recorded.

• Brand Name: SUTURE ANCHOR, PEEK PUSHLOCK SP
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10515583
• Report Number: 1220246-2020-02148
• Device Sequence Number: 14281977
• Product Code: HWC
• UDI-Device Identifier: 00888867022980
• UDI-Public: 00888867022980
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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 Expiration Date: 09/30/2024
• Device Model Number: SUTURE ANCHOR, PEEK PUSHLOCK SP
• Device Catalogue Number: AR-1922PSM-1
• Device Lot Number: 10401450
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other