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

Model Number	13911009
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the company has determined that the subject event in this mdr is likely not reportable, the company has decided to file this mdr in an abundance of caution and to ensure full compliance with 21cfr part 803.
Event or Problem Description
After sterilization had been completed and the instruments were being put back into the trays it was noticed that the tip of the screwdriver had broken off.The tip was not located, and it is unsure when the breakage occurred.
Event or Problem Description
After sterilization had been completed and the instruments were being put back into the trays it was noticed that the tip of the screwdriver had broken off.The tip was not located, and it is unsure when the breakage occurred.
Additional Manufacturer Narrative
Initial report - although the company has determined that the subject event in this mdr is likely not reportable, the company has decided to file this mdr in an abundance of caution and to ensure full compliance with 21cfr part 803.Supplemental report - as this issue was noticed post-surgery-sterilization, it is unsure as to when the screwdriver tip broke.The company has decided to file an mdr out of an abundance of caution to ensure full compliance with 21cfr part 803.The device was returned to the manufacturer for analysis, which concluded that the two main causes of screwdriver shaft breakage are due to a bending stress applied to the instrument during surgery, and torsion stress applied to the instrument by the surgeon suring surgery.

• Brand Name: ERISMA-LP MIS
• Common Device Name: SCREWDRIVER SHAFT
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 11453367
• Report Number: 3009962553-2021-00001
• Device Sequence Number: 17270846
• Product Code: HXX
• 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): 02/22/2021

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: Other
• Device Model Number: 13911009
• Device Catalogue Number: 13911009
• Device Lot Number: JA01N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1