MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DUAL CUT SAGITTAL BLADE (25 X 1.27 X 100MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICA

Catalog Number 4125127100

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that the blade broke at the mount and at the side and slipped out of the handpiece.It was also reported that the patient's patella tendon was cut and a suture anchor was used which resulted in a three minute delay.It was also reported that the procedure was completed successfully.

Manufacturer Narrative

The failure was confirmed via photographs provided.Investigation results indicate that from review of the photographs of the broken blade that was provided and information provided related to the event, the blade came into contact with the cutting block during the procedure.This repeated contact with the cutting block could potentially cause the blade to break.This cannot be confirmed as the blade was not returned for evaluation.

Event Description

It was reported that the blade broke at the mount and at the side and slipped out of the handpiece.It was also reported that the patient¿s patella tendon was cut and a suture anchor was used which resulted in a three minute delay.It was also reported that the procedure was completed successfully.

• Brand Name: DUAL CUT SAGITTAL BLADE (25 X 1.27 X 100MM)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICA
• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 6699033
• MDR Text Key: 79568387
• Report Number: 0001811755-2017-01369
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 4546540216977
• UDI-Public: (01)4546540216977
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4125127100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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