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	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was returned to (b)(4) for analysis on august 9th, 2019.The instrument was lost and it is unclear where the instrument was lost after being shipped from (b)(4).As such, no analysis was able to be performed.
Event or Problem Description
Mis screwdriver tip broke intraoperatively.The screwdriver became disengaged from the screw during insertion.Upon removing the screw driver from the patient, the tech noticed that the tip of the screwdriver was broken.It was not seen on xrays of the patient or found in the surgical field.A second screwdriver was used in its place and the surgery completed without any further complications.

• 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: 9532954
• Report Number: 3009962553-2019-00010
• Device Sequence Number: 2407705
• 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
• Report Date (Section B): 12/30/2019

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: 08/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1