MAUDE Adverse Event Report: SYMMETRY MEDICAL MANUFACTURING, INC. FULL TOOTH ACETABULAR REAMER 420 SERIES; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 39-420147

Device Problem Material Integrity Problem (2978)

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

Event Date 03/14/2022

Event Type  malfunction  

Event Description

Acetabular reamer was broken.

• Brand Name: FULL TOOTH ACETABULAR REAMER 420 SERIES
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYMMETRY MEDICAL MANUFACTURING, INC.; 486 west 350 north; warsaw IN 46582
• Manufacturer Contact: michael parrish ; 486 west 350 north; warsaw, IN 46582 ; 5742678700
• MDR Report Key: 16922071
• MDR Text Key: 315126151
• Report Number: 3004776227-2023-02412
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39-420147
• Device Catalogue Number: 16-033-047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1