MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P HALF DOSE 1 PACK; BONE CEMENT

Catalog Number	6188-1-001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicates the devices were manufactured and accepted into final stock with no reported discrepancies.Lot ray019 is made up of powder lot 584mx1 and liquid lot 931jx which were also review and no discrepancies noted.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Glass ampoule body from simplex p half dose broke into multiple pieces while opening.Surgical tech stated that he placed one hand on the ampoule body and placed his other hand on the polyethylene sleeved tip.While attempting to open the ampule the glass body "exploded" into pieces.The glass ampoule was not wrapped in a sterile gauze as recommended in the technique guide.
Additional Manufacturer Narrative
An event regarding ampoule breaking into multiple pieces during opening of a simplex liquid ampoule was reported.The event was not confirmed.Device evaluation and results: 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.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 ampoule breaking into multiple pieces 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 or Problem Description
Glass ampoule body from simplex p half dose broke into multiple pieces while opening.Surgical tech stated that he placed one hand on the ampoule body and placed his other hand on the polyethylene sleeved tip.While attempting to open the ampule the glass body "exploded" into pieces.The glass ampoule was not wrapped in a sterile gauze as recommended in the technique guide.

• Brand Name: SIMPLEX P HALF DOSE 1 PACK
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6891956
• Report Number: 0002249697-2017-02834
• Device Sequence Number: 16169988
• Product Code: LOD
• UDI-Device Identifier: 07613327128437
• UDI-Public: 07613327128437
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K062553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 6188-1-001
• Device Lot Number: RAY019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR