MAUDE Adverse Event Report: SYMMETRY MEDICAL MANUFACTURING, INC. MATTA CAPSULAR RETRACTOR; REUSABLE SURGICAL INSTRUMENT

Model Number	259807008
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient had his hip replaced by the surgeon and during the procedure the capsular retractor got entangled in the acetabular reamer and broke.All of the pieces were retrieved but did cause approximately at 20 minute delay.The surgery finished without incident and all pieces were retrieved.

• Brand Name: MATTA CAPSULAR RETRACTOR
• Common Device Name: REUSABLE SURGICAL INSTRUMENT
• 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: 16982641
• Report Number: 3004776227-2023-02909
• Device Sequence Number: 20540273
• Product Code: GAD
• UDI-Device Identifier: 00847538010695
• UDI-Public: 847538010695
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 259807008
• Device Catalogue Number: 13-121-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown