MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	10/28/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 10/31/2022, it was reported by a sales representative via email that an ar-8928bcj-cp achilles speedbridge implant system was explanted during a revision surgery on (b)(6) 2022.Additional information received on 10/31/2022.An ar-8928bcj-cp achilles speedbridge implant system and an abs-4200-034 amnion were implanted during original procedure on 2/18/2022.Due to chronic inflammation and pain, revision surgery was performed, and ar-8928bcj-cp was removed.Both surgeries occurred at the same facility.

• Brand Name: IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP
• 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: 15834873
• Report Number: 1220246-2022-05777
• Device Sequence Number: 17433748
• Product Code: MAI
• UDI-Device Identifier: 00888867251991
• UDI-Public: 00888867251991
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/21/2022

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: 08/31/2023
• Device Model Number: IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP
• Device Catalogue Number: AR-8928BCJ-CP
• Device Lot Number: 14270432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 11/21/2022
• Date Device Manufactured: 10/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown