MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ION NITRIDED BLADE; INSTRUMENT, CAST REMOVAL, AC-POWERED

Catalog Number 0940023000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device not returned to manufacturer for evaluation.

Event Description

It was reported that when the nurse was removing the cast on the forearm, the patient received 2 cuts that were 1.5cms to 2.0cms long and started to bleed.It was also reported that the wounds were put together and the patient received wound dressings.It was further reported that there was no infection as a result of this event and no additional treatment is expected.

Manufacturer Narrative

The cast cutter blade and the concomitant cast cutter ((b)(4)) reported involved with this event were returned for evaluation.Measurements performed on the returned blade against part print specification indicated that the blade met all measurements performed.Investigation results for both the cast cutter and the blade indicate the reported failure could not be confirmed.The definitive root cause could not be determined.

Event Description

It was reported that when the nurse was removing the cast on the forearm, the patient received 2 cuts that were 1.5cms to 2.0cms long and started to bleed.It was also reported that the wounds were put together and the patient received wound dressings.It was further reported that there was no infection as a result of this event and no additional treatment is expected.

• Brand Name: ION NITRIDED BLADE
• Type of Device: INSTRUMENT, CAST REMOVAL, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: dervillia murphy ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 5492356
• MDR Text Key: 40067669
• Report Number: 0001811755-2016-00282
• Device Sequence Number: 1
• Product Code: LGH
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0940023000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other