• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR. PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR. PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-1-705E
Device Problems Use of Device Problem (1670); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 07/18/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Upon removal of 6541-1-705e the pegs were left in the patients leg. They were immediately retrieved with a needle holder. Broken instrument on the left leg. No harm to the patient.

 
Manufacturer Narrative

An event regarding pin disassociation of a triathlon guide was reported. The event was confirmed. Method & results: device evaluation and results: inspection of the returned device confirmed the both pins had dissociated from the device body. Medical records received and evaluation: not performed as there was no indication that patient factors contributed to the reported event. Device history review: all devices accepted into final stock conformed to specification. This review confirmed the device was manufactured prior to capa implementation. Complaint history review: there have been no similar previous reported events. Conclusions: a capa investigation was completed. The investigation concluded that the fixation peg disassociating from the triathlon 4:1 express cutting block was caused by a manufacturing nonconformance. It was concluded that the supplier, seabrook international, had not performed the required press fit operation between the peg and block which led to the pin coming out of the assembly. Stryker reserves the right to re-evaluate this investigation if additional relevant information becomes available.

 
Event Description

Upon removal of (b)(4) the pegs were left in the patients leg. They were immediately retrieved with a needle holder. Broken instrument on the left leg. No harm to the patient.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR.
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 colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5878297
MDR Text Key52177236
Report Number0002249697-2016-02609
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123486
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 07/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-1-705E
Device LOT NumberSB6H74
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/15/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/09/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/16/2016 Patient Sequence Number: 1
-
-