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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO HUDSON/MODIFIED TRINKLE ATTACHMENT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO HUDSON/MODIFIED TRINKLE ATTACHMENT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 6203135000
Device Problems Fracture (1260); Fitting Problem (2183)
Patient Problems Abrasion (1689); Infiltration into Tissue (1931)
Event Date 05/08/2021
Event Type  Injury  
Event Description
It was reported by the user facility that the surgeon was reaming the acetabular wall when something in the drill reamer broke, which caused the reamer to start rotating oblong causing the reamer to damage the anterior wall.The surgeon stopped when he felt the reamer break in his hand and there was an additional hour to surgery to facilitate priming for alternate company shell/liner.
 
Event Description
It was reported by the user facility that the surgeon was reaming the acetabular wall when something in the drill reamer broke, which caused the reamer to start rotating oblong causing the reamer to damage the anterior wall.The surgeon stopped when he felt the reamer break in his hand and there was an additional hour to surgery to facilitate priming for alternate company shell/liner.
 
Manufacturer Narrative
Supplemental report submitted to document device evaluation results.Corrected data in d9.
 
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Brand Name
HUDSON/MODIFIED TRINKLE ATTACHMENT
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key11951573
MDR Text Key254789081
Report Number3015967359-2021-01063
Device Sequence Number1
Product Code HWE
UDI-Device Identifier04546540501684
UDI-Public04546540501684
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6203135000
Device Catalogue Number6203135000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received09/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age70 YR
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