Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L34MM; SCREW, FIXATION, BONE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L34MM; SCREW, FIXATION, BONE Back to Search Results
Model Number 656434
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 04/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
 
Event or Problem Description
It was reported that during a right posterior malleolus case, the head of a 34 mm 2.7 non-locking screw broke off when removing from the plate.The screw was being removed due to it being too long at implantation.The screw was left in the patient, and more screws were used in the other holes.There was no surgical delay.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BONE SCREW, T8 FULL THREAD, 2.7MM/L34MM
Common Device Name
SCREW, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
MDR Report Key11739887
Report Number0008031020-2021-00196
Device Sequence Number14559702
Product Code HWC
UDI-Device Identifier07613327068931
UDI-Public07613327068931
Combination Product (Y/N)N
Initial Reporter StateNH
Initial Reporter CountryUS
PMA/510(K) Number
K180500
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician Assistant
Type of Report Initial
Report Date (Section B) 04/28/2021
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 Number656434
Device Catalogue Number656434
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/01/2021
Initial Report FDA Received Date04/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-