MAUDE Adverse Event Report: LDR MÉDICAL BODY OF THE ROI-C IMPLANT HOLDER; 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	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the hook on two roi-c inserters fractured off while installing the cages intra-operatively.The final cage was successfully installed using one of the broken inserters.The fractured pieces were recovered and there were no patient impacts.This is report two of two for this event.
Additional Manufacturer Narrative
Inspection visual inspection revealed that the tips of both devices were fractured off.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.Reference report 3004788213-2022-00048.

• Brand Name: BODY OF THE ROI-C IMPLANT HOLDER
• 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: 14853042
• Report Number: 3004788213-2022-00049
• Device Sequence Number: 14721001
• Product Code: LXH
• UDI-Device Identifier: 03662663043649
• UDI-Public: (01)03662663043649(10)610323104/05
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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: 610323104/05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2017
• 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: Male