MAUDE Adverse Event Report: ARTHREX, INC. 8 MM SINGLE USE OATS SET; ORTHOPEDIC MANUAL SURG INSTR

Model Number	8 MM SINGLE USE OATS SET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On (b)(6)2023, it was reported by an arthrex employee via sems that an ar-1981-08s osteochondral autograft transfer systems tip broke.This occurred during a procedure.There was no additional information provided, additional information has been requested.Additional information was provided on (b)(6)2023, it was reported that this event occurred during an oats procedure.All fragments were retrieved from the patient, and the case was completed using another ar-1981-08s.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1981-08s was received for investigation.The returned device was visually inspected and it was noted that the recipient harvest rod was damaged.The tip¿s diameter of the rod has nicks and dents.  the method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause for the reported failure is an improper surgical technique.Per dfu-0070, rev.1.F.Precautions.1.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.E.Warnings.3.Oats only: autograft transplantation requires careful harvesting, precise sizing, and accurate placement of osteochondral autograft cylinders (grafts) with hyaline cartilage from a donor joint to a recipient joint.4.Oats only: the length of the harvested osteochondral graft, referred to as donor, must precisely match the length of the socket created in the osteochondral lesion, referred to as (recipient).5.Oats only: when inserting the osteochondral graft (donor) into the osteochondral socket (recipient), do not countersink the hyaline cartilage graft.6.Oats only: past and current scientific publications, surgical technique manuals, or surgical technique training on any media (print, dvd, video) relating to osteochondral autograft transplantation should be reviewed prior to the procedure.

• Brand Name: 8 MM SINGLE USE OATS SET
• 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: 17379884
• Report Number: 1220246-2023-07282
• Device Sequence Number: 12282764
• Product Code: LXH
• UDI-Device Identifier: 00888867025332
• UDI-Public: 00888867025332
• 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): 11/01/2024

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: 8 MM SINGLE USE OATS SET
• Device Catalogue Number: AR-1981-08S
• Device Lot Number: 21641222727
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown