MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PRECISION THIN (9.0 X 0.38 X 25.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number 2296003111

Device Problems Fracture (1260); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.

Event Description

It was reported that there was a potential sterility breach on the packaging of two devices.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.This record addresses one of the instances reported.

Manufacturer Narrative

B5 & h6: additional information provided.The quality investigation is complete.H3 other text : device not returned.

Event Description

It was reported that there was a potential sterility breach on the packaging of two devices.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.Update: both blades broke in half inside the packaging.This record addresses one of the instances reported.

• Brand Name: PRECISION THIN (9.0 X 0.38 X 25.0MM)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 13012455
• MDR Text Key: 282294286
• Report Number: 3015967359-2021-02723
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540046499
• UDI-Public: 04546540046499
• 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: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2296003111
• Device Catalogue Number: 2296003111
• Device Lot Number: 21162067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: No
• 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