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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS TIBIA STYLUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER ORTHOPAEDICS-MAHWAH GMRS TIBIA STYLUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 64969068
Device Problems Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2019
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
The tibial stylus from the gmrs all poly preparation tray should be engraved with 12mm and 18mm as per the operative technique.The instrument in the tray had the correct catalogue number, but instead was engraved with 15mm and 20mm.The surgeon wanted a 12mm resection, so had to use the 15mm marking, then move the block on the pins to resect 13mm of tibia.
 
Event Description
The tibial stylus from the gmrs all poly preparation tray should be engraved with 12mm and 18mm as per the operative technique.The instrument in the tray had the correct catalogue number, but instead was engraved with 15mm and 20mm.The surgeon wanted a 12mm resection, so had to use the 15mm marking, then move the block on the pins to resect 13mm of tibia.
 
Manufacturer Narrative
An event regarding a product marking discrepancy involving a gmrs stylus was reported.The event was confirmed based on evaluation of the returned device.Method & results: device evaluation and results: visual inspection was performed on the returned device, catalog 6496-9-068, lot id lsnd43.The gmrs stylus is (laser) marked 15mm and 20mm.The surface finish on some areas of the stylus appears to have been belted/machined.There is no weld present adjacent to the lot id marking on the stylus housing.Dimensional inspection was performed on the returned device.The distance from the flat on the underside of each tip of the "wing" of the stylus to the bottom of the plunger/stylus housing are both outside of specification.The distance as per the drawing c-pe-6496-9-068 are 18.0mm and 12.00mm.The distances on the returned device are 20.02mm and 14.96mm.Clinician review: 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 reported product marking discrepancy on the gmrs stylus is confirmed.Visual inspection was performed on the returned device, catalog 6496-9-068, lot id lsnd43.The gmrs stylus is (laser) marked 15mm and 20mm.The surface finish on some areas of the stylus appears to have been belted/machined.There is no weld present adjacent to the lot id marking on the stylus housing.Dimensional inspection was performed on the returned device.The distance from the flat on the underside of each tip of the "wing" of the stylus to the bottom of the plunger/stylus housing are both outside of specification.The distance as per the drawing c-pe-6496-9-068 are 18.0mm and 12.00mm.The distances on the returned device are 20.02mm and 14.96mm.The manufacturing cell reviewed the event and returned stylus instrument and stated: from the investigation it was found that when the part was shipped from stryker on the 30th nov 2002 it was within specification (12mm & 18mm) as per drawing, as the part now measures to the makings present on the returned device it can be concluded from stryker investigation that the part was modified/adulterated after it left stryker control.As per the instructions for use "the design of the instrument may not be modified in any way." no further investigation or action is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
GMRS TIBIA STYLUS
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8977495
MDR Text Key187606399
Report Number0002249697-2019-03147
Device Sequence Number1
Product Code LXH
UDI-Device Identifier07613327205695
UDI-Public07613327205695
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 11/15/2019
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 Catalogue Number64969068
Device Lot NumberLSND43
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2019
Initial Date Manufacturer Received 08/13/2019
Initial Date FDA Received09/09/2019
Supplement Dates Manufacturer Received10/18/2019
Supplement Dates FDA Received11/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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