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

Catalog Number	MC9001R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report, and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that during the surgery, the hook on the implant holder fractured.An alternative implant holder was used to complete the procedure.There were no impacts to the patient.
Event or Problem Description
It was reported that during the surgery, the hook on the implant holder fractured.An alternative implant holder was used to complete the procedure.There were no impacts to the patient.
Additional Manufacturer Narrative
Additional information in d4: serial number, d8, and h6: component, investigation type, findings, and conclusions.This device is used for treatment.No medical records were provided with the complaint.Inspection the product was not returned for evaluation, but a photo was provided.When reviewing the photo, it was difficult to see if the hook on the end of the instrument was actually fractured.The complaint remains unrefuted.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 zimmer biomet¿s control.Potential root cause a definitive root cause can not be determined with the information provided.It is possible that an off-axis force applied to the implant holder or wear and tear from multiple uses over time contributed to this event.The complaint description also mentions that the implant holder was "too tight," which may have contributed to this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: investigation type.This report is relaying additional information.Inspection: the returned item matches information in the complaint file, visual inspection confirms that the hook is fractured.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that during the surgery, the hook on the implant holder fractured.An alternative implant holder was used to complete the procedure.There were no impacts to the patient.

• Brand Name: 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
• MDR Report Key: 10937357
• Report Number: 3004788213-2020-00200
• Device Sequence Number: 641331
• Product Code: LXH
• UDI-Device Identifier: 03662663043168
• UDI-Public: (01)03662663043168(10)210205613/24
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2021

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: MC9001R
• Device Lot Number: 210205613/24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 03/09/2021; 07/01/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 03/12/2021; 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 73