MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM PERC INSERT KIT FOR FIBERTAK; MANUAL INSTR, GENERAL SURGICAL

Model Number	1.8MM PERC INSERT KIT FOR FIBERTAK
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 13th february 2024, it was reported by a sales rep.Via email that for an ar-3610pk-3, fibertak®, percutaneous insertion kit, the surgeon who regularly used the 1.8 knotless fibertak percutaneous drill kit, when he tried to place the switching stick down the drill sleeve, there was an item blocking it.This drill sleeve had just come out of the disposable kit and had not been used prior.On further inspection the scrub nurse inserted the switching stick into the drill guide and a metal shaving came out of the drill guide.This was detected during use in an arthroscopic shoulder stabilization procedure on (b)(6) 2024.The procedure was completed successfully with a reusable drill guide.The drill sleeve was used and then discarded.The sales rep.Does have the metal shavings that were forced out of the drill guide.22nd february 2024 - the sales rep.Responded that the malfunctioning drill guide was used once the blockage was cleared, the reusable guide they had on consignment was used for the first two anchors.This was slotted, so it did cause issues with suture management, hence the disposable was used for the final anchor.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the customer-provided photo, which shows the ar-3610pk-3 had metal shaving.The most likely cause for the reported failure can be attributed to a manufacturing issue.

• Brand Name: 1.8MM PERC INSERT KIT FOR FIBERTAK
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 18810636
• Report Number: 1220246-2024-01227
• Device Sequence Number: 18213521
• Product Code: LXH
• UDI-Device Identifier: 00888867358225
• UDI-Public: 00888867358225
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 1.8MM PERC INSERT KIT FOR FIBERTAK
• Device Catalogue Number: AR-3610PK-3
• Device Lot Number: 15164916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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