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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED S2 Ø5X25 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED S2 Ø5X25 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 17965025S
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/27/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains implanted.
 
Event or Problem Description
On (b)(6) a customer reported the following event : "after a surgery, the pharmacist realized that an expired locking screw ref 17965025s has been implanted on a patient.The device was out-of- date for several months (exact date unknown).The customer asked if it is critical and if we have any studies on this point.".
 
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Brand Name
LOCKING SCREW, FULLY THREADED S2 Ø5X25 MM
Common Device Name
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key8006514
Report Number0009610622-2018-01358
Device Sequence Number1525395
Product Code HSB
UDI-Device Identifier04546540399700
UDI-Public04546540399700
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K032579
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Pharmacist
Type of Report Initial
Report Date (Section B) 10/25/2018
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 Lay User/Patient
Device Catalogue Number17965025S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/27/2018
Initial Report FDA Received Date10/25/2018
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;
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