MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; SCREW, FIXATION, BONE

Model Number	2101-0200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The trident impaction handle broke during the impaction of a trident window trial during surgery.The window trial got stuck and very difficult to get out and got deformed.No harm to the patient.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a cutting edge impactor was reported.The event was confirmed via evaluation of the provided photograph of the device.Method & results: product evaluation and results: the reported device was not returned however a photograph was provided for review.The photograph shows that the strike plate has fractured off the end of the impactor.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the impactor broke during surgery.The reported device was not returned however a photograph was provided for review.The photograph shows that the strike plate has fractured off the end of the impactor.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Not returned to the manufacturer.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16821811
• Report Number: 0002249697-2023-00433
• Device Sequence Number: 15200383
• Product Code: HWC
• UDI-Device Identifier: 07613327211511
• UDI-Public: 07613327211511
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K123604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: 2101-0200
• Device Catalogue Number: 2101-0200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown