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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PEG DRILL SIZE 1-2 BIT, DRILL

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STRYKER ORTHOPAEDICS-MAHWAH PEG DRILL SIZE 1-2 BIT, DRILL Back to Search Results
Catalog Number 5650-4-512A
Device Problems Device Difficult to Setup or Prepare; Inadequacy of Device Shape and/or Size
Event Date 08/06/2019
Event Type  Injury  
Manufacturer Narrative

Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other events for the lot referenced. Device evaluation is anticipated but not yet begun. A supplemental report will be submitted upon completion of the investigation.

 
Event Description

On (b)(6) 2019 knee joint replacement did. On (b)(6) 2019, the patient complained of pain and had a fracture in the tibia. At first, dr. Decided that it was a technical problem, but there was a fracture starting from the extension of the inner peg. # 2 had the same length as the peg # 3, # 1 and # 2 are too long. There are no revisions, etc. , and follow-up is in progress.

 
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Brand NamePEG DRILL SIZE 1-2
Type of DeviceBIT, DRILL
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
collin neitzel
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key8994515
Report Number0002249697-2019-03180
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue Number5650-4-512A
Device LOT NumberSC6C13
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/22/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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