MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG 10CC HYDROSET INJECTABLE CEMENT; IMPLANT

Catalog Number 79-43910

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device was discarded at the facility; however, pictures were supplied to the manufacturer.

Event Description

It was reported that prior to surgery, the surgeon proceeded to open the hydroset packaging and noticed that there was a hair in half of the sterile portion and half outside the sterile packaging.The company representative was not available for the case.

Manufacturer Narrative

A confirmation of the reported event was not applicable because neither the complained device nor a photo evidence was provided for investigation.The investigation conducted is based on the reviews of the batch manufacturing records (bmr).The device is manufactured by (b)(4).So the complaint information was forwarded to the manufacturing facility.The reviews of the bmr were completed and no discrepancies were recorded.It has been confirmed that the product and its components (liquid and powder components) were manufactured per validated conditions.Further possible root causes for the potentially identified hazard (particle/debris) are according to the risk management file: excessive forces (e.G.Moving, positioning, holding).Wrongly assembled instruments/ implants.Occurring during shipping/ transportation.Based on the evaluation no indications for any design, material or manufacturing related problems were found in this investigation.Device was not returned.

Event Description

It was reported that prior to surgery, the surgeon proceeded to open the hydroset packaging and noticed that there was a hair in half of the sterile portion and half outside the sterile packaging.The company representative was not available for the case.

• Brand Name: 10CC HYDROSET INJECTABLE CEMENT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5571271
• MDR Text Key: 43033270
• Report Number: 0008010177-2016-00070
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 79-43910
• Device Lot Number: T955HIC02008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: No
• 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