MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK SP, 4.75X24.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	PEEK SWIVELOCK SP, 4.75X24.5MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2019
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 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 shoulder arthroscopy on (b)(6) 2019 a hardware failure occurred with an arthrex implant that became loose inside the patient.Due to the failure a revision surgery on (b)(6) 2019 was necessary.Additional information obtained 14-jan-2020.Further information were provided by the customer.It was reported that the customer uses the sos system to follow up on the patient who indeed had complications.However it was reported that the event was not related to the arhtrex anchor.The patient had other complications which resulted in the loose anchor.Dr (b)(6) has removed the anchor due to the complications but stated that the problem itself was not related to the anchor itself.Additional information obtained 24-jan-2020.The explanted part number has been provided: ar-2324pslm-1, peek swivelock sp.

• Brand Name: PEEK SWIVELOCK SP, 4.75X24.5MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9693153
• Report Number: 1220246-2020-01649
• Device Sequence Number: 14168270
• Product Code: MAI
• UDI-Device Identifier: 00888867098152
• UDI-Public: 00888867098152
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K151342
• 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): 02/11/2020

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: No Information
• Device Model Number: PEEK SWIVELOCK SP, 4.75X24.5MM
• Device Catalogue Number: AR-2324PSLM-1
• Device Lot Number: 10265246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other