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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 16MM; SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.
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STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 16MM; SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER. Back to Search Results
Catalog Number 2030-6516-1
Medical Device Problem Code Packaging Problem (3007)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/28/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
 
Event or Problem Description
It was reported that, during a tha, when a nurse peeled the outer tyvek sheet, the inner blister also picked up with outer tyvek and fell down on the floor.
 
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Brand Name
6.5 CANCELLOUS BONE SCREW 16MM
Common Device Name
SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7156810
Report Number0002249697-2018-00001
Device Sequence Number11020869
Product Code HWC
UDI-Device Identifier07613327036978
UDI-Public07613327036978
Combination Product (Y/N)N
PMA/510(K) Number
K894124
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/02/2018
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 Date07/06/2022
Device Catalogue Number2030-6516-1
Device Lot Number5E4KX0
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/05/2017
Initial Report FDA Received Date01/02/2018
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;
Patient Age58 YR
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