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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH ANCHORAGE 2 CP REAMER FOR CROSS-PLATES; PLATE, FIXATION, BONE

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STRYKER GMBH ANCHORAGE 2 CP REAMER FOR CROSS-PLATES; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 705172
Medical Device Problem Code Dull, Blunt (2407)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/23/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
 
Event or Problem Description
As reported: "used both reamers and they were not reaming.Very dull.".
 
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Brand Name
ANCHORAGE 2 CP REAMER FOR CROSS-PLATES
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ   2545
Manufacturer Contact
dannielle stap
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key24922337
Report Number0008031020-2026-00565
Device Sequence Number13336906
Product Code HRS
UDI-Device Identifier07613327131055
UDI-Public07613327131055
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K151769
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Health Professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/22/2026
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 Number705172
Device Lot Number9763AB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Follow-Up
Initial Date Received by Manufacturer 03/23/2026
Supplement Date Received by Manufacturer05/28/2026
Initial Report FDA Received Date04/20/2026
Supplement Report FDA Received Date06/22/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured01/12/2026
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Reuse
Patient Sequence Number1
Patient SexFemale
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