MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 11CM LONG ATTACH; MOTOR, DRILL, ELECTRIC

Model Number	LONG-G1
Medical Device Problem Codes	Vibration (1674); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Concomitant med products and therapy dates: burr device, (b)(6) 2021.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the burr device falling out of the attachment device was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was observed that the device experienced vibration, had worn bearings and there was pitting on the spacers.It was further determined that the device failed pretest for vibration assessment.Therefore, the reported condition of vibration was confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.Udi: (b)(4).
Event or Problem Description
It was reported that during pre-surgery testing, it was discovered that the burr device kept falling out of the attachment device.During in-house engineering evaluation, it was observed that the device experienced vibration.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 11CM LONG ATTACH
• Common Device Name: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11548114
• Report Number: 1045834-2021-00388
• Device Sequence Number: 11550447
• Product Code: HBC
• UDI-Device Identifier: 00845384016335
• UDI-Public: 00845384016335
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2021

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: LONG-G1
• Device Catalogue Number: LONG-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1