MAUDE Adverse Event Report: CLARIANCE SAS ERISMA LP; TUBE

Model Number	18912026
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The breakage of the quick-connect rod was caused by an incorrect assembly of the screwdriver before use.When the screwdriver shaft is not properly engaged in the quick-connect rod, this causes the breakage of the strips by interfering with the window of the screwdriver tube.
Event or Problem Description
The surgeon initially implanted a 7.5mm diameter polyaxial screw and was unable to release the locking mechanism of the screwdriver.As a consequence, the surgeon removed the polyaxial screw initially implanted.He used another screwdriver readily available in the set and replaced the 7.5mm diameter polyaxial screw with a 8.5mm diameter polyaxial screw.No patient harm was reported and the surgery was completed with no further complications.

• Brand Name: ERISMA LP
• Common Device Name: TUBE
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 9157930
• Report Number: 3009962553-2019-00003
• Device Sequence Number: 2430842
• Product Code: HXX
• UDI-Device Identifier: 03700780625178
• UDI-Public: (01)03700780625178
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K153326
• 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): 09/19/2019

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: 18912026
• Device Catalogue Number: 18912026
• Device Lot Number: G903N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1