MAUDE Adverse Event Report: CLARIANCE SAS ERISMA-LP; ERISMA REDUCTION SCREWDRIVER SHAFT

Model Number	18911040
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The tips of the erisma drivers broke off while the dr.Inserting the reduction and simultaneously pulling laterally to retract tissue.The same action broke two drivers in the period of 5 minutes.There was no harm to the patient.
Additional Manufacturer Narrative
Two shafts #1891040 of the reduction polyaxial screwdriver broke during surgery.The tips broke off while the surgeon was inserting the screw and simultaneously pulling laterally to retract tissue.However, no patient harm was reported, and the surgery was able to be completed without further incident.This event is reportable as a malfunction.
Additional Manufacturer Narrative
Two shafts #1891040 of the reduction polyaxial screwdriver broke during surgery.The tips broke off while the surgeon was inserting the screw and simultaneously pulling laterally to retract tissue.However, no patient harm was reported, and the surgery was able to be completed without further incident.This event is reportable as a malfunction.Analysis report conclusion 08/12/2022: the two main causes of the screwdriver shaft breakage are due to a bending stress applied to the instrument by the surgeon during surgery, and torsion stress applied to the instrument by the surgeon during surgery.This particular breakage was caused by torsion stress.
Event or Problem Description
The tips of the erisma drivers broke off while the dr.Inserting the reduction and simultaneously pulling laterally to retract tissue.The same action broke two drivers in the period of 5 minutes.There was no harm to the patient.

• Brand Name: ERISMA-LP
• Common Device Name: ERISMA REDUCTION SCREWDRIVER 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: 14454753
• Report Number: 3009962553-2022-00001
• Device Sequence Number: 5175212
• Product Code: HXX
• UDI-Device Identifier: 03700780625239
• UDI-Public: (01)03700780625239
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120469
• 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): 05/19/2022

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 Model Number: 18911040
• Device Catalogue Number: 18911040
• Device Lot Number: JAA1X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2019
• 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