MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ALIGNMENT HANDLE; INSTRUMENT

Catalog Number 6541-2-807

Device Problem Sticking (1597)

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

Event Date 02/19/2015

Event Type  malfunction  

Event Description

When opening trays for case, scrub tech noticed sticky film on the handle which came off on the tech's glove.Handle was removed from field and a new set was opened to perform the case (no patient in room at time of discovery).After case concluded, all other sets were opened and inspected and additional handles were identified with same issue of sticky film on handles and were removed from use accordingly.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding a sticky handle involving a tibial alignment handle was reported.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review indicates there has been one other event for the lot referenced.Conclusion: when opening the trays for a case, the scrub technician noticed a sticky film on the handle.The handle was removed from field and a new set was opened to perform the case (no patient in room at time of discovery).There was no surgical procedure associated with the reported event.After case concluded, all other sets were opened and inspected and additional handles were identified with same issue of sticky film on handles and were removed from use accordingly and returned to stryker for evaluation.A visual inspection of the returned device confirms the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

When opening trays for case, scrub tech noticed sticky film on the handle which came off on the tech's glove.Handle was removed from field and a new set was opened to perform the case (no patient in room at time of discovery).After case concluded, all other sets were opened and inspected and additional handles were identified with same issue of sticky film on handles and were removed from use accordingly.

• Brand Name: TIBIAL ALIGNMENT HANDLE
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4609052
• MDR Text Key: 5694978
• Report Number: 0002249697-2015-00759
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• 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: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-2-807
• Device Lot Number: N3L13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other