MAUDE Adverse Event Report: LDR MÉDICAL ROI-C IMPLANT HOLDER BODY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	MC9091R-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3004788213-2021-00162.
Event or Problem Description
It was reported the hooks broke off the tip of two roi-c inserters during a product training.There was not a patient present.This is report one of two for this event.
Event or Problem Description
It was reported the hooks broke off the tip of two roi-c inserters during a product training.There was not a patient present.This is report one of two for this event.
Additional Manufacturer Narrative
Corrections in d4: udi number and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Inspection the returned devices were examined.Visual inspection revealed the hook has fractured off of both returned devices.Potential cause the root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimvie¿s control.Device usage this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: ROI-C IMPLANT HOLDER BODY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 12956746
• Report Number: 3004788213-2021-00161
• Device Sequence Number: 16608090
• Product Code: LXH
• UDI-Device Identifier: 03662663043649
• UDI-Public: (01)03662663043649(10)410153141/052
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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 Catalogue Number: MC9091R-1
• Device Lot Number: 410153141/052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2010
• 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 Sex: Unknown