MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P - CE TOBRA FD 10-PK; BONE CEMENT

Catalog Number 61971010

Device Problems Crack (1135); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2016

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.An event regarding glass shattering of a simplex liquid ampoule while opening the ampoule was reported.The event was confirmed.Method & results: device evaluation and results: the fractured ampoule was returned for evaluation without its original packaging.The ampoule nib was broken cleanly off.A section of the ampoule below the cracker is also broken.Six retain ampoules from the same simplex liquid lot were used for review.Visual inspection indicated that no unusual characteristics were observed and that the plastic crackers were present on the ampoules.Medical records received and evaluation: not performed as no medical records were provided.Device history review: the devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded that the reported shattering of the ampoule was confirmed.It was not known how the ampoules were opened, if the provided cracker for opening the ampoules was used.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.No further investigation for this event is possible at this time.If additional information becomes available this investigation will be reopened.

Event Description

The customer reported that the ampoules of the simplex p were breaking off at the wrong point.The glass came into the liquid four to five times.

• Brand Name: SIMPLEX P - CE TOBRA FD 10-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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6242017
• MDR Text Key: 64938250
• Report Number: 0002249697-2017-00173
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 37613327128742
• UDI-Public: (01)37613327128742(11)160323(17)170930(10)TCX011
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 61971010
• Device Lot Number: TCX011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• 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