MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN MEDPOR COATED TEAR DRAIN - 3.5; IMPLANT

Catalog Number 81120

Device Problems Material Separation (1562); Defective Component (2292)

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

Event Date 07/07/2015

Event Type  malfunction  

Event Description

It was reported that the facility noticed that the medpor tear drain was defective prior to a case - the medpor sleeve was separating from the glass tube and was able to slide up and down.

Manufacturer Narrative

The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.

Manufacturer Narrative

The reported event could be confirmed, because, it was possible to separate the medpor-coating from the glass tear drain tube after cleaning.According to the developing engineer it is possible to break the medpor coating away from the glass tube if it is handled too much or if the opening in the conjunctiva or the nasal bone is not large enough when the surgeon attempts to slide the medpor coated tear drain into the patient.In the instruction for use it is stated that: ¿the glass tube may separate from the medpor coating if excessive force is placed on the end of the glass tube while inserting the tube.Insert the tear drain as far as possible by grasping the drain by the medpor coating.¿ the dhr check confirmed that the complained device has been manufactured according to the specification.Summarizing these facts most likely the separation of the medpor-coating from the glass tear drain is a result of excessive forces applied by the customer during handling (traction overload).Based on the statistical evaluation there is no indication for any systematic design, material or manufacturing related issue.The complaint is added to the complaint trend.

Event Description

It was reported that the facility noticed that the medpor tear drain was defective prior to a case - the mepor sleeve was separating from the glass tube and was able to slide up and down.

• Brand Name: MEDPOR COATED TEAR DRAIN - 3.5
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: kelli dykstra ; boetzingerstr. 41; freiburg 79111 ; GM 79111 ; 76145120
• MDR Report Key: 4912599
• MDR Text Key: 6014488
• Report Number: 0008010177-2015-00161
• Device Sequence Number: 1
• Product Code: OKS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81120
• Device Lot Number: F001993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2010
• 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