MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,BIO-COMP ACHILLES SPEEDBRG; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a comp ft surgery the device got damaged.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device.It was not necessary to switch the surgical technique or do a second surgery.24-mar-2023 update dw: further information were provided that the anchor broke during the surgery.
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.
Additional Manufacturer Narrative
Complaint is confirmed.Visual evaluation noted that the implant was damaged on the threads, and the swivelock driver's outer sleeve was damaged on the tip.The probable cause of this condition is that the implant was assembled in the wrong direction and caused damage to the driver's sleeve and implant.The most probable cause is attributed to manufacturing issue.Functional testing was not performed due to the damage to the device.

• Brand Name: IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
• 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: 16785316
• Report Number: 1220246-2023-06568
• Device Sequence Number: 14872554
• Product Code: MAI
• UDI-Device Identifier: 00888867049123
• UDI-Public: 00888867049123
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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: IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
• Device Catalogue Number: AR-8928BC-CP
• Device Lot Number: 15046093
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown