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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SINGLE USE INSTRUMENTS - FEMORAL KIT (CR) - SIZE 3 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH SINGLE USE INSTRUMENTS - FEMORAL KIT (CR) - SIZE 3 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5555-2203
Device Problems Break (1069); Use of Device Problem (1670)
Patient Problems Abrasion (1689); No Consequences Or Impact To Patient (2199)
Event Date 09/28/2015
Event Type  Malfunction  
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Event Description

It was reported by the surgeon that the single use instrumentation shows strong abrasion and pieces broke off at the single use femur prothesis. The piece which broke off could be removed from the patient.

 
Manufacturer Narrative

An event regarding damage involving a single use instruments ¿ femoral kit (cr) size 3 was reported. The event was confirmed. Method & results: -device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 02-nov-2015. It was reported and concluded that damage to the posterior cutting guide slots was observed and most likely caused from associated oscillating cutting blade activated prior to cutting blade insertion into the slots. Conclusions: the investigation concluded that damage occurred most likely due to contact with oscillating cutting blade prior to cutting blade insertion into the slots. The surgical protocol specifically recommends fully inserting the saw blade into the slot prior to initiating oscillation. There is no indication the event was related to the design manufacturing or materials of the subject device.

 
Event Description

It was reported by the surgeon that the single use instrumentation shows strong abrasion and pieces broke off at the single use femur prothesis. The piece which broke off could be removed from the patient.

 
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Brand NameSINGLE USE INSTRUMENTS - FEMORAL KIT (CR) - SIZE 3
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5180424
MDR Text Key29990072
Report Number0002249697-2015-03454
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
PMA/PMN NumberK132624
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 09/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5555-2203
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/12/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2015
Was Device Evaluated By Manufacturer? Yes
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: 10/27/2015 Patient Sequence Number: 1
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