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

Model Number	LONG-G1
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2021
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.The actual device was returned for evaluation.Quality engineering evaluated the attachment device and the reported condition that the device will not lock onto the handpiece device was confirmed.An assessment was performed and it was determined the device failed the functional assessment, and the cutter insertion assessment due to the missing internal components.It was observed that the terminals were corroded, the device was missing internal components screw, bearing stack, bearing, spacer, long spacer, short spacer, spacer, and bushing, and the nose tube was bent.The device loctite joints were inspected, and no loctite residue was found on the threads of the components.It was noted that the remaining functional assessment could not be completed.It was determined that the lack of loctite on the loctite joint caused the internal components to be missing.It was determined that the root cause for the device falling apart and missing components was a manufacturing error, due to no loctite residue found on threads of components.It was determined that this was due to improper assembly.The root cause for the component damage and the bent nose tube was determined to be traced to user, which is user error.A review of the device history was performed and no non-conformances were detected related to the reported condition.Udi ¿ (b)(4).
Event or Problem Description
It was reported that the long attachment device would not lock onto the drill device.During in-house engineering evaluation it was observed that the device was missing internal components and was received apart.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.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 11CM LONG ATTACH
• 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: 11893714
• Report Number: 1045834-2021-00915
• Device Sequence Number: 11866474
• 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): 03/04/2021

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-G1
• Device Catalogue Number: LONG-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1