MAUDE Adverse Event Report: ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE; INTRAMED FIXATN ROD AND ACCESS

Model Number	FIBULOCK IMPLANT SYSTEM, STERILE
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On 6/16/2023, it was reported by a sales representative via email that the opening reamer from an ar-8973ds fibulock implant system got caught on the wire and could not advance.The wire was removed, and there was a noticeable bend and a bump where on the k-wire, where the drill looked to be getting stuck.Another wire was placed, and a new kit was opened because there were shavings on the drill, but the same thing happened again.The surgeon switched techniques and completed the case with a plate instead.This was discovered during a fibulock procedure on (b)(6) 2023.Additional information received on 6/16/2023: this was an ankle fracture procedure, and a plate from another manufacturer was used to complete it.The shavings from the drill were inside the patient, but it is unknown if everything was retrieved; it was difficult to see through the x-ray.
Additional Manufacturer Narrative
The complaint allegation is confirmed.Based on the images provided from the field, it is evident that the devices were damaged intra-operatively and arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to excessive user-applied mechanical forces.

• Brand Name: FIBULOCK IMPLANT SYSTEM, STERILE
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 17327574
• Report Number: 1220246-2023-07168
• Device Sequence Number: 12342036
• Product Code: HSB
• UDI-Device Identifier: 00888867303041
• UDI-Public: 00888867303041
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160069
• 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): 02/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FIBULOCK IMPLANT SYSTEM, STERILE
• Device Catalogue Number: AR-8973DS
• Device Lot Number: 15057841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown