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	Insufficient Information (4580)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/4/2021, it was reported by a sales representative via sems that an ar-8330h shaver handpiece displayed an h15 error and an ar-1510fs-7 flipcutter ratchet drill sleeve was broken.The handpiece issue was discovered during use and the guide issue was discovered after use, both from an acl reconstruction performed on (b)(6) 2021.The handpiece was replaced at the start of the case.The guide was found to be broken after the case, with clean bends at the tip with no reported jagged edges of fragments missing (see intake pictures).The case was completed with no reported patient effect.
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.
Additional Manufacturer Narrative
Complaint confirmed, the distal end of the guide is damaged and cracked, with material mushrooming outward.Circumferential abrasion marks were observed on the inner diameter surfaces near the proximal and distal end.A likely cause is prying/leveraging the device or the flipcutter 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: 12853778
• Report Number: 1220246-2021-03989
• Device Sequence Number: 17598349
• Product Code: MDM
• UDI-Device Identifier: 00888867196766
• UDI-Public: 00888867196766
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 12/10/2021

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: 152043
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown