MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.8 X 12.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number 0277096276

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during testing, the blade broke at the mount in the handpiece saw.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.

Manufacturer Narrative

The quality investigation is complete.Device not received.

Event Description

It was reported that during testing, the blade broke at the mount in the handpiece saw.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.

• Brand Name: RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.8 X 12.5MM)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8175344
• MDR Text Key: 130895956
• Report Number: 0001811755-2018-02814
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540880673
• UDI-Public: 04546540880673
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

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 Expiration Date: 07/01/2023
• Device Catalogue Number: 0277096276
• Device Lot Number: 18198017
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8206000000 (B)(4)