MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 12.4CM HEAVY DUTY LONG ATTCH; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number	LONG-HD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was traced to improper maintenance.Udi: (b)(4).
Event or Problem Description
It was reported that during a maintenance check, it was observed that the attachment device bearing was worn.During in-house engineering evaluation, it was determined that the device color banding had chipped/faded, had component damage and was corroded.The device also failed pretests for visual assessment and temperature.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.The date of event was unknown.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 12.4CM HEAVY DUTY LONG ATTCH
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12152365
• Report Number: 1045834-2021-01199
• Device Sequence Number: 17072082
• Product Code: HBC
• UDI-Device Identifier: 00845384003595
• UDI-Public: 00845384003595
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080802
• 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): 06/04/2021

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-HD
• Device Catalogue Number: LONG-HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1