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

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.

• Brand Name: SIMPLEX TOBRAMYCIN 1 PK
• Type of Device: BONE 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 Key: 6488802
• MDR Text Key: 72921642
• Report Number: 0002249697-2017-01246
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• 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 Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 61971001
• Device Lot Number: TAY002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other