MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT HOLDER; ROI-A ALIF CAGE SYSTEM

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
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.
Event or Problem Description
It was reported that an implant holder was discovered to have a cracked handle and a missing ball stop during surgery.There was no impact on the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and initially corrected information.The complaint is confirmed for one (1) of one (1) returned roi-a implant holder (pn ir9280r) for the failure of instrument being fractured and missed an instrument subcomponent.Visual inspection reveals two fractures (in handle, on shaft) and that the ball stop is missing.Medical records were not provided for review.Potential cause: the cause of the damage cannot be determined at this time since there is no information available regarding how the instrument was being used or handled at the time of the damage.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that an implant holder was discovered to have a cracked handle and a missing ball stop during surgery.There was no impact on the patient.

• Brand Name: ROI-A MEDIAN IMPLANT HOLDER
• Common Device Name: ROI-A ALIF CAGE SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, n/a 10300 ; FR 10300
• MDR Report Key: 11497604
• Report Number: 3004788213-2021-00015
• Device Sequence Number: 14577196
• Product Code: MAX
• UDI-Device Identifier: 03662663041768
• UDI-Public: (01)03662663041768(10)110227903/06
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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 Model Number: N/A
• Device Catalogue Number: IR9280R
• Device Lot Number: 110227903/06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1