MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH TIB ALIGN M/L TRANS TUBE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 71442165

Device Problem Break (1069)

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

Event Date 01/28/2024

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a tka surgery the orthomatch tib align m/l trans tube broke when adjusting the alignment.The procedure was resumed, after a non-significant delay, with the same device, and there was a change in the surgical technique.

Event Description

It was reported that during a tka surgery the orthomatch tib align m/l trans tube broke when adjusting the alignment.The procedure was resumed, after a non-significant delay, with the same device.Although, there was a change in the surgical technique.No patient complications were reported.

Manufacturer Narrative

B5, event description: corrected.

• Brand Name: ORTHOMATCH TIB ALIGN M/L TRANS TUBE
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18735735
• MDR Text Key: 336080218
• Report Number: 1020279-2024-00399
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556495100
• UDI-Public: 00885556495100
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K142807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71442165
• Device Lot Number: 18BSY0013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male