MAUDE Adverse Event Report: ARTHREX, INC. CORING REAMER, 9MM WITH COLLARED PIN; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CORING REAMER, 9MM WITH COLLARED PIN
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
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 04/17/2023, it was reported by a arthrex employee via sems that an ar-1223s coring reamer became deformed and broke.This was discovered during a case and broke during use.Per facility: "the product was used for arthroscopic bone graft harvesting from the talus on (b)(6) 2023.During use, the tip of the reamer touched the sheath of the camera scope, causing deformation and broken within the joint.At this time, it was also confirmed that metal powder was generated.The doctor in charge was able to extract a bone graft using the product as it was, but the bone hole was enlarged due to the deformation of the product.No further information is available.".
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1223s was received for investigation.Upon visual inspection of the two returned devices, it was observed that the cannulated coring reamer had teeth broken into two pieces, which were the only parts returned from this device.Additionally, the collared pin shaft was found to be slightly bent.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.This event is likely caused by prying/levering the device against hard bone or other instrumentation during use.

• Brand Name: CORING REAMER, 9MM WITH COLLARED PIN
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 16906579
• Report Number: 1220246-2023-06708
• Device Sequence Number: 12105308
• Product Code: LXH
• UDI-Device Identifier: 00888867005532
• UDI-Public: 00888867005532
• 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,Followup
• Report Date (Section B): 09/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CORING REAMER, 9MM WITH COLLARED PIN
• Device Catalogue Number: AR-1223S
• Device Lot Number: 14986381
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown