MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PROXIMAL ROD ASSEMBLY - JAPAN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7650-1956
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the proximal rod assembly spike part of the pptd instrument was damaged at the time of driving and remained inside the femur.It was found on the x-ray after the operation.When checking for damage before cleaning the instrument, it was discovered that there was no spike part.

• Brand Name: PROXIMAL ROD ASSEMBLY - JAPAN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9986029
• Report Number: 0002249697-2020-00788
• Device Sequence Number: 3896942
• Product Code: LXH
• UDI-Device Identifier: 07613327234022
• UDI-Public: 07613327234022
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: 7650-1956
• Device Catalogue Number: 7650-1956
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other