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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 25MM; SCREW, FIXATION, BONE
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STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 25MM; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 2030-6525-1
Medical Device Problem Code Particulates (1451)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/06/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event or Problem Description
It was reported that, during a tha, when a surgeon opened the inner blister package, he noticed a metal debris in the package.A spare screw was used instead.
 
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Brand Name
6.5 CANCELLOUS BONE SCREW 25MM
Common Device Name
SCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8477844
Report Number0002249697-2019-01513
Device Sequence Number1780837
Product Code HWC
UDI-Device Identifier07613327036992
UDI-Public07613327036992
Combination Product (Y/N)N
PMA/510(K) Number
K894124
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/03/2019
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 Expiration Date08/31/2023
Device Catalogue Number2030-6525-1
Device Lot NumberWM7LE8
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/06/2019
Initial Report FDA Received Date04/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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