MAUDE Adverse Event Report: ARTHREX, INC. DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 6/3/2024, a sales representative reported via sems-06584113 that an ar-3638dhc-2 disposables kit for knotless hip fibertak suture anchor 1.9 fluted drill bit broke off inside the socket when drilling with the 1.9-flute drill and advancing into the bone.The surgeon was able to retrieve the drill bit.The case was completed with another ar-3638dhc-2 disposables kit for knotless hip fibertak suture anchor.This was discovered during a hip labral repair procedure on (b)(6) 2024 with no reported patient harm.Additional information was received on 6/6/2024: the case was delayed 10 minutes due to retrieving the rest of the drill bit.There were no adverse effects on the patient and it was stated that they were unsure if additional anesthesia was administered.
Event or Problem Description
On 6/3/2024, a sales representative reported via (b)(4) that an ar-3638dhc-2 disposables kit for knotless hip fibertak suture anchor 1.9 fluted drill bit broke off inside the socket when drilling with the 1.9-flute drill and advancing into the bone.The surgeon was able to retrieve the drill bit.The case was completed with another ar-3638dhc-2 disposables kit for knotless hip fibertak suture anchor.This was discovered during a hip labral repair procedure on (b)(6) 2024 with no reported patient harm.Additional information was received on 6/6/2024: the case was delayed 10 minutes due to retrieving the rest of the drill bit.There were no adverse effects on the patient and it was stated that they were unsure if additional anesthesia was administered.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-3638dhc-2 serial/batch number (b)(6) was received for investigation.Visual evaluation found that the drill tip was broken off.No functional testing was performed as the device was received broken.The most likely cause for the reported failure can be attributed to improper bone prep, misaligned insertion, prying/leveraging the device during insertion.

• Brand Name: DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM
• 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: 19642972
• Report Number: 1220246-2024-06517
• Device Sequence Number: 21000952
• Product Code: LXH
• UDI-Device Identifier: 00888867430044
• UDI-Public: 00888867430044
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM
• Device Catalogue Number: AR-3638DHC-2
• Device Lot Number: 15192162
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown