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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US SLIDE RASP 22 X 28MM 16MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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STRYKER SPINE-US SLIDE RASP 22 X 28MM 16MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 48361267
Device Problems Mechanical Problem (1384); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2022
Event Type  malfunction  
Event Description
It was reported that a reliance slide rasp handle tip broke off within a reliance slide rasp trial intra-operatively.The rasp was successfully removed, an alternate device was used and surgery was completed successfully.No adverse consequences, surgical delay or medical intervention were reported.This report captures the trial.
 
Manufacturer Narrative
B5 was corrected.There was no issue reported with the rasp.The device was returned and no issue was identified via visual inspection therefore this device is concomitant.H6 coding has been updated to reflect device evaluation and investigation conclusion.
 
Event Description
It was reported that the rasp handle tip broke off within a rasp.The patient was unaffected and the procedure was completed successfully.There was no issue reported with the rasp.The device was returned and no issue was identified via visual inspection therefore this device is concomitant.This report captures the trial.
 
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Brand Name
SLIDE RASP 22 X 28MM 16MM
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key15053527
MDR Text Key304445558
Report Number0009617544-2022-00073
Device Sequence Number1
Product Code LXH
UDI-Device Identifier07613327269468
UDI-Public07613327269468
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/11/2022
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
Device Operator Health Professional
Device Model Number48361267
Device Catalogue Number48361267
Device Lot Number084523
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/21/2022
Initial Date FDA Received07/19/2022
Supplement Dates Manufacturer Received09/12/2022
Supplement Dates FDA Received10/11/2022
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
Patient Sequence Number1
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