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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER RASP SIZE 0 37.5/44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH EXETER RASP SIZE 0 37.5/44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 0580-3744-0
Device Problems Break (1069); Fracture (1260); Mechanical Jam (2983)
Patient Problem Injury (2348)
Event Date 05/23/2018
Event Type  Injury  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
Nib of exeter modular broach (44 #0) broke off while broach when trying to remove a fully inserted into femur.Broach could not be removed from patients femur using exeter broach handle.Various methods of removal were tried by surgeon before broach was removed after burring a hole into the proximal end and a slap hammer with a small hook attachment was inserted to backslap it out.Approximately 90mins added to procedure to remove instrument before surgery could be continued and completed.
 
Manufacturer Narrative
An event regarding a crack/fracture involving an exeter rasp was reported.The event was confirmed following visual inspection.Method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar).The parts were examined with the aid of a stereo microscope at magnifications up to 50x.The device broken at the notch.The fracture surfaces of the notch.Based on macroscopic features, the approximate direction of fracture propagation.Material analysis a material analysis has been performed.The report concluded: the rasp fractured at the notch, with the fracture occurring in overload.Eds showed the rasp was consistent with 17-4 ph stainless steel alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
 
Event Description
Nib of exeter modular broach (44 #0) broke off while broach when trying to remove a fully inserted into femur.Broach could not be removed from patients femur using exeter broach handle.Various methods of removal were tried by surgeon before broach was removed after burring a hole into the proximal end and a slap hammer with a small hook attachment was inserted to backslap it out.Approximately 90mins added to procedure to remove instrument before surgery could be continued and completed.
 
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Brand Name
EXETER RASP SIZE 0 37.5/44MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7616569
MDR Text Key111622861
Report Number0002249697-2018-01887
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327207705
UDI-Public07613327207705
Combination Product (y/n)N
PMA/PMN Number
K153345
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0580-3744-0
Device Lot NumberTDCE506
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Initial Date Manufacturer Received 05/23/2018
Initial Date FDA Received06/19/2018
Supplement Dates Manufacturer Received07/30/2018
Supplement Dates FDA Received08/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age78 YR
Patient Weight85
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