MAUDE Adverse Event Report: MATORTHO LIMITED SAIPH; TIBIAL BEARING IMPACTOR DRIVE

Model Number 293-262

Device Problem Material Fragmentation (1261)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

Incident report received from australia.Incidation tip failed in use and remained in situ in patella bearing device placed on maortet in early 2016 and use history is unclear.

Event Description

Surgeon as he had received post op xrays indicating the tip of the instrument (293-262) had broken off and was insitu in the tibial bearing in the patient.This was confirmed when i requested and received photos indicating that the instrument was in fact missing the tip.Surgeon was not aware this had occurred intraoperatively and at this stage he is not going back in to retrieve it.

• Brand Name: SAIPH
• Type of Device: TIBIAL BEARING IMPACTOR DRIVE
• Manufacturer (Section D): MATORTHO LIMITED; 19/20 mole business aprk; randalls road; leatherhead, surrey KT227 BA; UK KT227BA
• Manufacturer Contact: john tullett ; 19/20 mole business aprk; randalls road; leatherhead, surrey KT227-BA ; UK KT227BA
• MDR Report Key: 15678740
• MDR Text Key: 306896938
• Report Number: 3008985661-2021-00001
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 293-262
• Device Catalogue Number: 293-262
• Device Lot Number: 213776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male