MAUDE Adverse Event Report: CLARIANCE SAS ERISMA-LP MIS; ERISMA DRIVER SHAFT

Model Number	13911009
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noticed that the tip of the screwdriver had broken off.It was not located.It is unsure when the breakage occurred: prior to or during surgery.As a consequence, clariance will file an mdr, out of an abundance of caution, to ensure full compliance with 21cfr part 803.
Event or Problem Description
Drivers distal end is sheared off.It is unknown if this occurred prior to or during surgery.The tip was not found in the surgical site or on x-rays.There was no harm to the patient and no delay to the surgery.
Additional Manufacturer Narrative
It was noticed that the tip of the screwdriver had broken off.It was not located.It is unsure when the breakage occurred: prior to or during surgery.As a consequence, clariance will file an mdr, out of an abundance of caution, to ensure full compliance with 21cfr part 803.Supplemental report on 11/29/2023, now included with this filing is the analysis report from clariance sas.
Event or Problem Description
Drivers distal end is sheared off.It is unknown if this occurred prior to or during surgery.The tip was not found in the surgical site or on x-rays.There was no harm to the patient and no delay to the surgery.

• Brand Name: ERISMA-LP MIS
• Common Device Name: ERISMA DRIVER SHAFT
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• Manufacturer (Section G): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• Manufacturer Contact: magalie hennequin ; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 17739279
• Report Number: 3009962553-2023-00002
• Device Sequence Number: 7250856
• Product Code: LRZ
• UDI-Device Identifier: 03700780627271
• UDI-Public: 03700780627271
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K162367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023
• 2 Devices were Involved in the Event: 1 2

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: 13911009
• Device Catalogue Number: 13911009
• Device Lot Number: H632X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2017
• 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: Unknown