MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTSTIRE_PRODUCT; LAVAGE, JET

Catalog Number UNK_IPR

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2008

Event Type  Injury  

Event Description

It is alleged one piece of an unknown pulsed lavage system used during a 2008 knee replacement surgery broke off and was left inside the patient.The piece was discovered and removed during an exploratory surgery in 2020.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16555377
• MDR Text Key: 311424148
• Report Number: 3015967359-2023-00572
• Device Sequence Number: 1
• Product Code: FQH
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_IPR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2023
• 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