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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported, "omega3 plate impactor plastic section has broken during use.Surgeon substituted another general ortho instrument.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received impactor was found to be broken from junction where metallic handle connects with the impactor head.The device has been subjected to quite high non-axial impaction as a result of which one half side of the breakage surface shows abnormal breakage pattern while the other half is relatively cleanly separated.The rest of the damaged part including the compressed distal end, all indicates towards high impact forces being applied on the impactor.Note that this is a device which is subjected to consistent impact forces due to which the device has finally given up.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the failure is user related.There are signs of heavy impactions on the impactor as evident by the manner of deformation and breakage surface.Also, as the device is intentionally used for impaction, it is likely that a weakened structural integrity due to long usage and reprocessing cycles would have contributed to the failure.The op-tech states: ¿note: use gentle hammering only ¿ otherwise the impactor may be destroyed.¿ if any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "omega3 plate impactor plastic section has broken during use.Surgeon substituted another general ortho instrument.".

• Brand Name: IMPACTOR ASSEMBLY OMEGA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10708033
• Report Number: 0008031020-2020-02349
• Device Sequence Number: 3644688
• Product Code: LXH
• UDI-Device Identifier: 04546540113078
• UDI-Public: 04546540113078
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 07480L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR