MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2023
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 7/19/2023, it was reported by a sales representative via email that an ar-8928bcj-cp achilles speedbridge kit was missing the green drill guide and there was an extra power tap.This was discovered upon opening the package during a haglund and achilles procedure on (b)(6) 2023.The case was completed by opening another kit.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-8928bcj-cp kit serial/batch number (b)(6) was received for evaluation.Upon visual evaluation of the received devices, it was noted that the drill guide was missing.Two 4.75mm swivelock bone tap shorts were returned with the kit.According to bom (bill of materials) specifications, the kit includes one (1).Evaluation of the customer's attached picture confirms the complaint allegation and the received kit devices.The most likely cause of the reported failure is an internal manufacturing packaging process issue.However, our early warning process is currently evaluating this device.

• Brand Name: IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: emily shafer ; 8009337001
• MDR Report Key: 17571361
• Report Number: 1220246-2023-07539
• Device Sequence Number: 8258438
• Product Code: MAI
• UDI-Device Identifier: 00888867251991
• UDI-Public: 00888867251991
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 11/04/2024

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: 04/30/2025
• Device Model Number: IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP
• Device Catalogue Number: AR-8928BCJ-CP
• Device Lot Number: 15094906
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown