MAUDE Adverse Event Report: STRYKER GMBH IMPACTOR ASSEMBLY OMEGA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	704001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; hospital retained.
Event or Problem Description
As reported: black piece of omega plate impactor was damaged in case when being used for impaction on plate.
Event or Problem Description
As reported: black piece of omega plate impactor was damaged in case when being used for impaction on plate.
Additional Manufacturer Narrative
Correction: sections h3, h6 method code.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on past complaints and risk management file some of the possible causes are (but not limited to): too high impact force applied, use of high ph cleaning agents which weakens the structural strength of the polymer handle, etc.The operative technique guide warns the user that: ¿note: use gentle hammering only ¿ otherwise the impactor may be destroyed.¿ if any additional information is provided, the investigation will be reassessed.H3 other text : device was discarded.

• Brand Name: IMPACTOR ASSEMBLY OMEGA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10186783
• Report Number: 0008031020-2020-01755
• Device Sequence Number: 886192
• Product Code: LXH
• UDI-Device Identifier: 04546540113078
• UDI-Public: 04546540113078
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 704001
• Device Catalogue Number: 704001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1