MAUDE Adverse Event Report: STRYKER GMBH IMPACTOR ASSEMBLY OMEGA 3; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	704001
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
It was reported: "the surgeon was using the impactor to impact a side plate onto a lag screw.On impaction, the handle cracked and broke in 2 pieces.All debris removed-large pieces." additionally, it was reported; the procedure was extended however the length of the extension is unknown.No additional medical intervention, and no adverse consequences to the patient due to the surgical delay.
Additional Manufacturer Narrative
Correction - please refer to d9/h3 - product was returned for investigation, h6 method code.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received impactor was found to be damaged at the distal end.The device has been subjected to quite high non-axial impaction as a result of which one-half side of the breakage surface shows an abnormal breakage pattern while the other half is relatively cleanly separated.The rest of the damaged part including the compressed distal end, all indicate towards high impact forces being applied on the impactor.Note that this is a device where consistent high forces are being applied due to which there are chances of breakage of the device.It cannot be excluded that normal material wear also contributed to the failure over the years of usage.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 investigation, the root cause was attributed to a user-related issue.The manner of the breakage pattern indicates towards application of high non-axial impact forces.The device is meant for only gentle hammering.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported: "the surgeon was using the impactor to impact a side plate onto a lag screw.On impaction, the handle cracked and broke in 2 pieces.All debris removed-large pieces".Additionally, it was reported; the procedure was extended however the length of the extension is unknown.No additional medical intervention, and no adverse consequences to the patient due to the surgical delay.

• Brand Name: IMPACTOR ASSEMBLY OMEGA 3
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16229265
• Report Number: 0008031020-2023-00030
• Device Sequence Number: 5490394
• Product Code: LXH
• UDI-Device Identifier: 04546540113078
• UDI-Public: 04546540113078
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 704001
• Device Catalogue Number: 704001
• Device Lot Number: 24982H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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