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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 2 IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 2 IMPLANT Back to Search Results
Catalog Number 5521-B-200
Device Problems Device Disinfection Or Sterilization Issue (2909); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 08/20/2015
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The box for the base plate was removed and as the nurse began to open up the first package to drop the implant in the sterile field, the innermost package was stuck to the outer piece and partially pulled back. We decided not to risk any sterility issues and did not place the implant on the sterile field and used a different base plate. The implant was never completely opened and never placed on the sterile field.

 
Manufacturer Narrative

An event regarding a packaging issue involving a triathlon baseplate was reported. The event was confirmed. Method & results: -device evaluation and results: the inner blister lid had delaminated. It is possible the lid stuck to the outer blister lid and delaminated when the outer lid was peeled back. It is noted that both blisters showed evidence of complete seal transfer. There is no indication that the sterility of the device was compromised. -medical records received and evaluation: not performed as the event is not related to patient factors. -device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies. -complaint history review: there have been no other events for this lot. Conclusions: the inner blister lid had delaminated. It is possible the lid stuck to the outer blister lid and delaminated when the outer lid was peeled back. The root cause was determined to be a known packaging issue. Packaging innovations is aware of this, and has issued a memo.

 
Event Description

The box for the base plate was removed and as the nurse began to open up the first package to drop the implant in the sterile field, the innermost package was stuck to the outer piece and partially pulled back. We decided not to risk any sterility issues and did not place the implant on the sterile field and used a different base plate. The implant was never completely opened and never placed on the sterile field.

 
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Brand NameTRI TS BASEPLATE SIZE 2
Type of DeviceIMPLANT
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 Key5080526
MDR Text Key26248816
Report Number0002249697-2015-03041
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
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 08/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2020
Device Catalogue Number5521-B-200
Device LOT NumberSSDUD
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/02/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/28/2015
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: 09/16/2015 Patient Sequence Number: 1
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