MAUDE Adverse Event Report: ARTHREX, INC. 4MM CURVED TORPEDO; SAW BLADE

Model Number	4MM CURVED TORPEDO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
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 04/17/2024, it was reported by a sales representative via sems-06541778 that an ar-8400ctd torpedo blade broke while resecting a suture.This occurred during use in a case with no patient effect.Additional information requested.
Additional Manufacturer Narrative
Complaint allegation is confirmed.An ar-8400td, arrived unpackaged for inspection.Functional testing with the testing console and handpiece could not be performed because the device's inner and outer tubes were damaged.A visual inspection revealed damage to both the inner and outer tubes of the torpedo.The tip of the inner tube was broken off, resulting in a loss of geometry at the distal end.Additionally, the cutting tip of the outer tube exhibited nicks and damage.The event likely occurred due to the device being pried or levered against hard bone or other instruments during use.
Additional Manufacturer Narrative
Complaint allegation is confirmed.An ar-8400td, arrived unpackaged for inspection.Functional testing with the testing console and handpiece could not be performed because the device's inner and outer tubes were damaged.A visual inspection revealed damage to both the inner and outer tubes of the torpedo.The tip of the inner tube was broken off, resulting in a loss of geometry at the distal end.Additionally, the cutting tip of the outer tube exhibited nicks and damage.The event likely occurred due to the device being pried or levered against hard bone or other instruments during use.
Event or Problem Description
On 04/17/2024, it was reported by a sales representative via (b)(4) that an ar-8400ctd torpedo blade broke while resecting a suture.An ar-3636 did not deploy correctly so it needed to be removed and the surgeon elected to use the torpedo to remove the excess suture from the joint.It broke while resecting the suture.This occurred during use in a case with no patient effect.Additional information requested.Additional information was provided on 09/25/2024.Where the sales representative stated the ar-3636 was used when hard bone was encountered and the anchor did not fully seat.The repair suture could not pass through the anchor.All fragments were not retrieved from the patient, and another ar-3636 was used to proceed with the case.

• Brand Name: 4MM CURVED TORPEDO
• Common Device Name: SAW BLADE
• 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: 19286634
• Report Number: 1220246-2024-03093
• Device Sequence Number: 7658206
• Product Code: GFA
• UDI-Device Identifier: 00888867187801
• UDI-Public: 00888867187801
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 10/01/2024

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: 4MM CURVED TORPEDO
• Device Catalogue Number: AR-8400CTD
• Device Lot Number: 15095532
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 04/17/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 09/19/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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