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	09/17/2020
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: "the screw-on attachment (704001-1) of the plate hammer is broken".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation (although incomplete) and matches the alleged failure mode.Device inspection revealed the following: the received impactor head was found to be severely deformed around the distal end.The metallic handle was not received along with the head.The deformation around the distal end indicates towards application of abnormal amount of forces.Also, the outer surface shows unusual marks and scratches indicating towards long and prolonged usage.The product received was incomplete.Of the whole assembly, only the head was received, and the metal handle was not returned.Since the product identification is available only on the metal handle, the lot number could not be identified.Therefore, a product history review could not be performed.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 abnormal impactions evident quite clearly on the head portion of the device.Also, as the device is intentionally used for impaction, it is for sure that a weakened structured 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: "the screw-on attachment (704001-1) of the plate hammer is broken".

• 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: 10672179
• Report Number: 0008031020-2020-02323
• Device Sequence Number: 2562136
• Product Code: LXH
• UDI-Device Identifier: 04546540113078
• UDI-Public: 04546540113078
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/13/2020
• 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