MAUDE Adverse Event Report: INNOMED INC. INNOMED; HOHMANN RETRACTOR ORTHOLUCENT SQUARE TIP 16MM

Model Number	4558-R
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
For a fractured left hip, a hohmann retractor wqas usef.The tip ws weak and it bent.This was a radiolucent retractor, a kind that is not normally kept in the hip set.
Additional Manufacturer Narrative
Received notification from customer and requested that the device be sent in for evaluation.Customer agreed.Waiting to receive the device.Will provide results of evaluation in follow up report.

• Brand Name: INNOMED
• Common Device Name: HOHMANN RETRACTOR ORTHOLUCENT SQUARE TIP 16MM
• Manufacturer (Section D): INNOMED INC.; 130 estus drive; savannah FL 31404
• Manufacturer (Section G): GSELL MEDICAL PLASTICS AG; pilatusstrasse 32; ch-5630 muri ag, ; SZ
• Manufacturer Contact: fernando fondra ; pilatusstrasse 32; ch-5630 muri ag ; SZ
• MDR Report Key: 14074311
• Report Number: 1833053-2022-00002
• Device Sequence Number: 4813779
• Product Code: GAD
• UDI-Device Identifier: 00840277118981
• UDI-Public: 00840277118981
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

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: 4558-R
• Device Catalogue Number: 4558-R
• Device Lot Number: 0916GSL
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White