MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTS_PRODUCT; LIGHT, SURGICAL, FIBEROPTIC

Catalog Number UNK_INS

Device Problem Fracture (1260)

Patient Problem Breast Discomfort/Pain (4504)

Event Date 02/09/2021

Event Type  Injury  

Event Description

Per the customer the patient was experiencing pain after a mastectomy.The patient underwent additional surgery and a piece of the device was removed.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.Attempts are being made to obtain additional information from the user facility.

Manufacturer Narrative

Discarded by user.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document the device was not available for evaluation.H3 other text : no product return.

Event Description

Per the customer the patient was experiencing pain after a mastectomy.The patient underwent additional surgery and a piece of the device was removed.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.Upon follow up, the user facility was not able to provide any further information regarding the reported event.

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• Type of Device: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 14025073
• MDR Text Key: 288771676
• Report Number: 3015967359-2022-00613
• Device Sequence Number: 1
• Product Code: FSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2023
• 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