MAUDE Adverse Event Report: ARTHREX, INC. OSTEOAUGER BONE GRAFT HARVESTER, 6MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	OSTEOAUGER BONE GRAFT HARVESTER, 6MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is confirmed.(1) unpackaged abs-8000-06 was received for evaluation.Visual inspection revealed no apparent issues with the device.Attempts to unscrew the two parts by hand were unsuccessful.With the mechanical assistance of two pliers, the devices were able to be unscrewed.The threading on both parts was undamaged, but friction between the two threads is present.When the devices are re-screwed together by hand, they stick, but unscrewing is possible without the assistance of additional mechanical devices.A probable cause can be attributed to over-tightening.
Event or Problem Description
On 05/18/2022, it was reported by a sales representative via sems that the surgeon was unable to untwist/take apart the device to retrieve the abs-8000-06 bone graft.This occurred during an unspecified procedure.The case was completed by using a new abs-8000-06 with no patient harm.

• Brand Name: OSTEOAUGER BONE GRAFT HARVESTER, 6MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18952662
• Report Number: 1220246-2024-01618
• Device Sequence Number: 12532231
• Product Code: LXH
• UDI-Device Identifier: 00888867377042
• UDI-Public: 00888867377042
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 03/21/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: OSTEOAUGER BONE GRAFT HARVESTER, 6MM
• Device Catalogue Number: ABS-8000-06
• Device Lot Number: 14945080
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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