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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TROCHANTERIC GRIP PLATE PLATE, FIXATION, BONE

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STRYKER ORTHOPAEDICS-MAHWAH TROCHANTERIC GRIP PLATE PLATE, FIXATION, BONE Back to Search Results
Catalog Number 6704-3-082
Device Problems Device Difficult to Setup or Prepare (1487); Difficult to Advance (2920)
Patient Problem Bone Fracture(s) (1870)
Event Date 04/14/2017
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

 
Event Description

After applying the tension to the cable, attempted to crash the hole of the plate through which the cable passed in order to fix the cable, but it did not crash easily. As a result a bone fracture occurred. Surgeon changed the plate to a longer size and continued the procedure.

 
Manufacturer Narrative

Reported event: an event regarding periprosthetic fracture involving a trochanteric grip system was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as no device was returned. Medical records received and evaluation: no information was received for review with a clinical consultant. Device history review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies. Complaint history review indicated there have been no other similar events for the reported lot. Conclusions: the exact cause of the event could not be determined, because insufficient information was provided. Further information such as x-rays, return of device, operative reports, patient history & follow up notes are needed to investigate this event further. If additional information and/or device become available, this investigation will be reopened.

 
Event Description

After applying the tension to the cable, attempted to crash the hole of the plate through which the cable passed in order to fix the cable, but it did not crash easily. As a result a bone fracture occured. Surgeon changed the plate to a longer size and continued the procedure.

 
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Brand NameTROCHANTERIC GRIP PLATE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6561918
MDR Text Key74985327
Report Number0002249697-2017-01519
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
PMA/PMN NumberK070170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/15/2020
Device Catalogue Number6704-3-082
Device LOT NumberG5767333
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/15/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/11/2017 Patient Sequence Number: 1
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