MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4-8 KEEL PUNCH GUIDE; INSTRUMENT

Catalog Number 6541-2-748

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

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, each is being returned for evaluation.

Manufacturer Narrative

Reported event: an event regarding a sticky handle involving a keel punch guide was reported.Review of the device history records indicates (b)(4) devices were manufactured and accepted into final stock between 22-aug-2005 and 19-oct-2005 with no reported discrepancies.Conclusion: 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.

• Brand Name: SIZE 4-8 KEEL PUNCH GUIDE
• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4685251
• MDR Text Key: 5710694
• Report Number: 0002249697-2015-01164
• 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
• Report Date: 02/19/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 6541-2-748
• Device Lot Number: NZL02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2015
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2005
• 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