MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTSTIRE_PRODUCT; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number UNK_ICO

Device Problem Fracture (1260)

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

H6: a follow up report will be filed once the quality investigation is complete.H3 other text: awaiting confirmation if device is available.

Event Description

It was reported that the blade broke at the mount.It was also reported there were no delays and no adverse consequences as a result of this event.No further information was provided.

Event Description

It was reported that the blade broke at the mount.It was also reported there were no delays and no adverse consequences as a result of this event.No further information was provided.

Manufacturer Narrative

D9 & h6: the device was not returned for evaluation.The quality investigation is complete.H3 other text : device not returned.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• 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: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 17895020
• MDR Text Key: 325242734
• Report Number: 3015967359-2023-02084
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ICO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• 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
• Treatment: 4508000000, S/N: (B)(6).