MAUDE Adverse Event Report: ARTHREX, INC. MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX CC; BIO SOFT TISSUE FIXATN FASTNR

Model Number	MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX CC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/15/2024, an fda medwatch notification was received via email.A facility representative reported that during drilling for the placement of a distal interference screw, a small fragment of the drill bit was noticed in the calcaneal wound.The fragment was verified by fluoroscopy.This was discovered during a procedure on (b)(6)2024.Additional information received on 7/18/2024: the broken drill was part of an ar-9928bck-mis fibertak achilles speedbridge implant system.The broken fragments were not removed, as a retrieval attempt would have been more problematic.The case was not delayed, and additional anesthesia was not needed.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged cannulated drill bit lot number: 032321 that is part of an ar-9928bck-mis mini-open fibertak® achilles speedbridge¿ repair implant system lot number: 15222869 was received for investigation.Visual evaluation noted that the tip of the device was broken and a fragment was missing.Dimensional testing was performed using a caliper id: 1003729.The length of the device was measured and found to be 3.330, indicating that the missing fragment is around.050, as the length dimension specified in drawing c20663 rev 8 is 3.380.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion and/or prying/leveraging the device during use.

• Brand Name: MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX 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: 19905044
• Report Number: 1220246-2024-07017
• Device Sequence Number: 18359618
• Product Code: HWC
• UDI-Device Identifier: 00888867389533
• UDI-Public: 00888867389533
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K201749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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 Model Number: MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX CC
• Device Catalogue Number: AR-9928BCK-MIS
• Device Lot Number: 15222869
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2024
• 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