MAUDE Adverse Event Report: SMITH & NEPHEW INC., ENDOSCOPY DIVISION SIZE 6 CUTTING BLOCK; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71441145

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/18/2022

Event Type  malfunction  

Event Description

Th cutting block was removed out of the patient during surgery and the surgeon noticed that a pin had broken off and was still in the patient's bone.Dr.(b)(6) chose not to try to retrieve it due to risk of removal.Fda safety report id # (b)(4).

• Brand Name: SIZE 6 CUTTING BLOCK
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; andover MA 01810
• MDR Report Key: 15311440
• MDR Text Key: 298978209
• Report Number: MW5111758
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71441145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: White