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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L18MM; SCREW, FIXATION, BONE
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STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L18MM; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 656418
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 03/12/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional becomes available, it will be provided in a supplemental report.Device evaluated by mfr: hospital disposed.
 
Event or Problem Description
It was reported that, during a primary procedure on a left distal radius, when seating the non-locking screw, the head broke off just as it was fully seating.The screw shaft was left in the patient and surgery was completed successfully with a surgical delay of less than one minute.No adverse consequences were reported.
 
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Brand Name
BONE SCREW, T8 FULL THREAD, 2.7MM/L18MM
Common Device Name
SCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8457928
Report Number0008031020-2019-00331
Device Sequence Number14144710
Product Code HWC
UDI-Device Identifier07613327068955
UDI-Public07613327068955
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K180500
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/27/2019
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 Catalogue Number656418
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/12/2019
Initial Report FDA Received Date03/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age17 YR
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