MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 12.4 CM HEAVY DUTY LONG ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Model Number	LONG-HD-G1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi ¿ (b)(4).
Event or Problem Description
It was reported that during an unspecified surgical procedure it was observed that the long attachment device fell apart.It was reported that there was a minimal delay in the procedure due to the event.It was not reported if there was a spare device available for use.There was 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 will be submitted accordingly.

• Brand Name: 12.4 CM HEAVY DUTY LONG ATTACHMENT
• Common Device Name: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11901062
• Report Number: 1045834-2021-00921
• Device Sequence Number: 11083446
• Product Code: HBC
• UDI-Device Identifier: 00845384016342
• UDI-Public: 00845384016342
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/20/2021

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-G1
• Device Catalogue Number: LONG-HD-G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1