MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK C, 5.5X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	PEEK SWIVELOCK C, 5.5X19.1MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the ar-2323pslc, was damaged when the implant was inserted.Used a new product and the case is completed.No adverse effect on the patient.Additional information provided 7/8/21: procedure being performed was an arcr.The seated depth of implant was about half.The bone quality of the patient was hard.All broken fragments were collected and retrieved.The case was completed by using a new ar-2323pslc.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-2323pslc (no batch indicator provided) was received for investigation.Visual inspection identified that the peek eyelet and implant were not present on the returned device.Inspection under magnification revealed that the distal end of the molded driver sleeve was damage.No fragments were returned for assessment.The cause remains undetermined, although it was recorded that the bone quality encountered during the procedure was "hard".The method used to prepare the bone during the procedure was not provided.A probable cause can be attributed to improper preparation of the hard bone encountered.

• Brand Name: PEEK SWIVELOCK C, 5.5X19.1MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12231654
• Report Number: 1220246-2021-03437
• Device Sequence Number: 17493524
• Product Code: MAI
• UDI-Device Identifier: 00888867026797
• UDI-Public: 00888867026797
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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 Expiration Date: 01/31/2025
• Device Model Number: PEEK SWIVELOCK C, 5.5X19.1MM
• Device Catalogue Number: AR-2323PSLC
• Device Lot Number: 10620424
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1