MAUDE Adverse Event Report: DRILL, 4.5MM CANNULATED; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	DRILL, 4.5MM CANNULATED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
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
It was reported that during knee arthroscopy surgery the cannulated drill did break off.The broken off piece has been retrieved from the patient.There was no harm for patient, operator or third party reported.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.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1204.5l, batch 03033015 was received for investigation.Visual inspection identified that the cannulated drill was returned in three distinct pieces, with breakage evident at the distal end of the shaft and along one of the flutes of the shaft.It was determined using digital caliper id: 011 that approximately 0.2250" of the shaft broke, and additionally, 0.5515" of one of the drill flutes had broken off.Assessment with gauge mmi 283 identified that the shaft width of the drill met design specifications.The cause remains undetermined.

• Brand Name: DRILL, 4.5MM CANNULATED
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• MDR Report Key: 12506571
• Report Number: 1220246-2021-03678
• Device Sequence Number: 18395876
• Product Code: HWE
• UDI-Device Identifier: 00888867004009
• UDI-Public: 00888867004009
• 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,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: DRILL, 4.5MM CANNULATED
• Device Catalogue Number: AR-1204.5L
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1