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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX TOBRAMYCIN 1 PK BONE CEMENT

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STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX TOBRAMYCIN 1 PK BONE CEMENT Back to Search Results
Catalog Number 61971001
Device Problems Break (1069); Crack (1135); Contamination of Device Ingredient or Reagent (2901)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2017
Event Type  Malfunction  
Manufacturer Narrative

The event involves a device that is not cleared for sale in the u. S. , but similar device is commercially available in the u. S.

 
Event Description

It was reported that the nurse noticed a shard of glass of the monomer vessel broke off during opening. The shard allegedly landed in the mixing bowl and required forceps to retrieve. Item was reported to be retrieved with forceps.

 
Manufacturer Narrative

An event regarding a shard of glass breaking during opening of a simplex liquid ampoule was reported. The event was not confirmed. Method & results: device evaluation and results: the open ampoule and cracker/plastic cap were returned in a screw top container with the lot details from the unit carton taped to the taped to the lid. There is evidence of a clean break on the neck of the ampoule. Two shards of the ampoule glass were also received with the returned product, one of the shards appears to be covered in a white powder most likely simplex powder. Medical records received and evaluation: not performed as no medical records were provided. Device history review: indicates all ten packs were manufactured and accepted into final stock on with no reported discrepancies. Complaint history review: there has been no other similar event for the lot referenced. Conclusions: an event regarding a shard of glass breaking during opening of a simplex liquid ampoule was reported. Testing of retain ampoules from the same lot resulted in the ampoules breaking as intended, i. E. Clean breaks with no visible fissures or excessive fragments of glass. The reported event could not be replicated. No further investigation for this event is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

It was reported that the nurse noticed a shard of glass of the monomer vessel broke off during opening. The shard allegedly landed in the mixing bowl and required forceps to retrieve. Item was reported to be retrieved with forceps.

 
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Brand NameSIMPLEX TOBRAMYCIN 1 PK
Type of DeviceBONE CEMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6488802
MDR Text Key72921642
Report Number0002249697-2017-01246
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2018
Device Catalogue Number61971001
Device LOT NumberTAY002
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/10/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/12/2017
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: 04/12/2017 Patient Sequence Number: 1
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