MAUDE Adverse Event Report: ARTHREX, INC. OSTEOCON FLAP REPR SINGSHOT INST; ORTHOPEDIC MANUAL SURG INSTR

Model Number	OSTEOCON FLAP REPR SINGSHOT INST
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the thicker end of the disposable drill, which is clamped in the jacob's chuck, is broken off on two devices.There was no harm or adverse event for patient, operator or third party reported.This was noticed before the surgery.No further information received.Update avoe 21-aug-2023: it was confirmed that it is unknown if the device broke during a surgery, but the breakage point would have been outside of the patient, as the breakage was at the level of the machine's jacob's chuck.Update avoe 21-aug-2023: it was confirmed that the error occurred during a chondral dart cartilage flake refixation surgery when drilling with the devices.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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
Additional information: h6 the complaint was confirmed.Two unpackaged drills ar-4009s batch 14938650 were received for evaluation.(the osteocon flap repair single-shot instrument kit only contains one drill).It is concluded that the second received device comes from a different batch.Visual evaluation found that both devices were detached/broken from the hub at the weld.Device#1 was broken at the weld from the hub.Device# 2 was detached from the hub.That could be the reason one device shaft is larger than the other.A functional test rolling the device on the surface plate id#650 found that both shafts were bent.The most likely cause(s) for the reported failure can be attributed to user error, improper bone preparation, misaligned insertion, or excessive forces through leveraging/prying the device.

• Brand Name: OSTEOCON FLAP REPR SINGSHOT INST
• 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: 17731374
• Report Number: 1220246-2023-07861
• Device Sequence Number: 14908019
• Product Code: LXH
• UDI-Device Identifier: 00888867031272
• UDI-Public: 00888867031272
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/27/2024

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: OSTEOCON FLAP REPR SINGSHOT INST
• Device Catalogue Number: AR-4009S
• Device Lot Number: 14938650
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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
• Patient Sex: Unknown