MAUDE Adverse Event Report: INNOMED, INC. NAMBA HIP SLIDE 22-40 MM HEADS; RETRACTOR

Model Number	6890
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was asked to return the device for inspection and evaluation.This submission is the initial report.A follow up report will be provided when results of the inspection and evaluation are complete.
Event or Problem Description
While surgeon was using skid, the tip broke and all particles removed.Skid removed and replaced.Broken skid sent cpd.

• Brand Name: NAMBA HIP SLIDE 22-40 MM HEADS
• Common Device Name: RETRACTOR
• Manufacturer (Section D): INNOMED, INC.; 103 estus drive; savannah GA 31404
• Manufacturer (Section G): TECOMET; 3724 n. state road; warsaw IN 46582
• Manufacturer Contact: irene davis ; 103 estus dr.; savannah, GA 31405 ; 9122360000
• MDR Report Key: 18716579
• Report Number: 1833053-2024-00001
• Device Sequence Number: 20772813
• Product Code: GAD
• UDI-Device Identifier: 00840277103925
• UDI-Public: 00840277103925
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2024

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: 6890
• Device Catalogue Number: 6890
• Device Lot Number: 0513S
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2013
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White