MAUDE Adverse Event Report: ARTHREX, INC. 3.9MM PEEK SWIVELOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	3.9MM PEEK SWIVELOCK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
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
On (b)(6) 2022, it was reported by via email that while using a ar-2326pslc-1, 3.9mm peek swivelock, the surgeon was shuttling the anchor to the hole and the eyelet broke off.This was discovered during use and the patient was involve.To complete the procedure, another anchor has been use.

• Brand Name: 3.9MM PEEK SWIVELOCK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 15484226
• Report Number: 1220246-2022-05534
• Device Sequence Number: 12734485
• Product Code: MAI
• UDI-Device Identifier: 00888867341982
• UDI-Public: 00888867341982
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K101823
• 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
• Report Date (Section B): 09/26/2022

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: 3.9MM PEEK SWIVELOCK
• Device Catalogue Number: AR-2326PSLC-1
• Device Lot Number: 14982250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown