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

Model Number	13911009
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Upon receipt inspection of a set after a transfer, the initial reporter noticed the tip was broken from an mis screwdriver shaft in the set.The tip was not located in the set.The instrument was not used in any surgeries by the initial reporter.
Event or Problem Description
Upon receipt inspection of a set after a transfer, the initial reporter noticed the tip was broken from an mis screwdriver shaft in the set.The tip was not located in the set.The instrument was not used in any surgeries by the initial reporter.
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.(b)(6) 2019 - as this issue was identified upon receipt inspection and the device was not used during a surgery, 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 in a state which made analysis impossible.As such, no analysis was able to be performed.However, the manufacturer has identified that the two main causes of 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.

• 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: 9142501
• Report Number: 3009962553-2019-00006
• Device Sequence Number: 2617064
• Product Code: HXX
• UDI-Device Identifier: 03700780627271
• UDI-Public: (01)03700780627271
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162367
• Number of Events Summarized: 1
• Summary Report (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): 09/20/2019

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: 13911009
• Device Catalogue Number: 13911009
• Device Lot Number: H632X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1