MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP RADIOLUCENT RIGHT ANGLE DRIVE; DRILLING POWER TOOL ATTACHMENT, BASIC

Model Number	4100355000
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	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rivets fell off of the device.Attempts are being made to obtain additional information from the user facility.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that the rivets fell off of the device.No medical intervention and no adverse consequences were reported with this event.As this event occurred after a procedure at the end user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: RADIOLUCENT RIGHT ANGLE DRIVE
• Common Device Name: DRILLING POWER TOOL ATTACHMENT, BASIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 15652229
• Report Number: 3015967359-2022-01967
• Device Sequence Number: 2455373
• Product Code: HRX
• UDI-Device Identifier: 04546540068279
• UDI-Public: 04546540068279
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: K943323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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
• Device Model Number: 4100355000
• Device Catalogue Number: 4100355000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown