MAUDE Adverse Event Report: ARTHREX, INC. STEPPED, RATCHET DRILL SLEEVE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	STEPPED, RATCHET DRILL SLEEVE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
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
It was reported that during a revision anterior cruciate ligament surgery the wheel mechanism of the flipcutter ar-1204ff (lot 22f21) failed to close the device to the neutral position resulting in the flipcutter failing to close.The surgeon used a spinal needle to clear the debris to get the flipcutter into the neutral position to remove it from the joint.During this process damage was done to the drill guide ar-1510fs-7.Pictures provided by the customer of the ar-1510fs-7 show that a part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same devices.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint is confirmed.One unpackaged ar-1510fs-7 ratcheting drill sleeve for flipcutter serial/batch number: (b)(6) was received for investigation.Functional testing was not performed due to the broken shaft.Visual evaluation found that the shaft tip of the drill was broken off.No fragments were returned for analysis.More in-depth visual evaluation found scratches and nick on the broken tip.The root cause of the reported failure mode is undetermined; however, the observed event is most likely caused by excessive forces applied during use.

• Brand Name: STEPPED, RATCHET DRILL SLEEVE
• 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: 15958929
• Report Number: 1220246-2022-05917
• Device Sequence Number: 5229487
• Product Code: MDM
• UDI-Device Identifier: 00888867196766
• UDI-Public: 00888867196766
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 02/28/2023

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: STEPPED, RATCHET DRILL SLEEVE
• Device Catalogue Number: AR-1510FS-7
• Device Lot Number: 152024
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown