MAUDE Adverse Event Report: ARTHREX, INC. 3.9MM BC ACHILLES PARS/ AMSS CC; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.9MM BC ACHILLES PARS/ AMSS CC
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information received on 10/1/2024: the metal shavings were noticed on the final x-ray during the achilles speedbridge procedure.The debris was not removed, and all the implants in the kit were used in the procedure.At this time, there is no plan for a revision surgery.The case was completed in a normal fashion, with no delayed, and no additional anesthesia was needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was observed debris in the x-rays provided.Also, the cannulated drill bit c20663-01 of the 3.9mm bc achilles pars/amss cc had the flutes broken off.No broken pieces were returned for investigation.Functional testing was not performed due to the damage to the device.The most probable cause for the reported failure is due to misaligned insertion, prying/leveraging, and/or the user applying excessive mechanical forces upon insertion.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 9/27/2024, it was reported by a sales representative via (b)(4) that the cannulated drill bit from an ar-9929bc-cp pars achilles midsubstance speedbridge implant system left metal shavings in the patient's calcaneus.No additional information was provided.

• Brand Name: 3.9MM BC ACHILLES PARS/ AMSS CC
• 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: jared engle ; 8009337001
• MDR Report Key: 20359943
• Report Number: 1220246-2024-07987
• Device Sequence Number: 15253738
• Product Code: HWC
• UDI-Device Identifier: 00888867389564
• UDI-Public: (01)00888867389564(11)240426(17)280331(10)15240308
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K201749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2025

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 BC ACHILLES PARS/ AMSS CC
• Device Catalogue Number: AR-9929BC-CP
• Device Lot Number: 15240308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: Not provided; 12/31/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/11/2024; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2024
• 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