MAUDE Adverse Event Report: ARTHREX, INC. 2.4MM BIO-SUTURETAK DISPOSABLES KIT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	2.4MM BIO-SUTURETAK DISPOSABLES KIT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.One unpackaged ar-1934-24ds was received for investigation.Visual inspection identified that the drill bit had seized inside the guide.Using digital micrometer id: 224, it was revealed that approximately 9.082mm of the drill bit's distal tip had fragmented.Additionally, the proximal end of the drill bit had also broken off.The cause remains undetermined, although a probable cause can be attributed to prying/leveraging the drill within the guide, leading to friction between the components.
Event or Problem Description
On 01/06/2022 it was reported by a arthrex representative via sems that an ar-1934-24ds, the drill bit breakage stacked in the drill guide, the tip of the drill was damaged.The case was completed using the new product in the same lot.No patient harms.Additional information 1/13/2022: on 01/13/2022 it was reported by a arthrex representative via sems that an ar-1934-24ds, during a procedure the drill but was stuck inside the drill guide.The drill tip was damaged during drilling, no debris came off the device.The case was competed using a new ar-1934-24ds.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: 2.4MM BIO-SUTURETAK DISPOSABLES KIT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13839475
• Report Number: 1220246-2022-04612
• Device Sequence Number: 5812792
• Product Code: MDM
• UDI-Device Identifier: 00888867023864
• UDI-Public: 00888867023864
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/21/2022

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 Expiration Date: 01/31/2026
• Device Model Number: 2.4MM BIO-SUTURETAK DISPOSABLES KIT
• Device Catalogue Number: AR-1934-24DS
• Device Lot Number: 12753075
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown