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

Model Number	18911039
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual examination at the macroscopic level revealed that the fracture was located at the distal tip of the screwdriver shaft.The fractured tip was not provided for analysis.The fracture analysis report suggests that the driver underwent a bending overload on the hex lobes of the shaft, arising from an improper handling of the instrument.A review of the device history record has been conducted.No issue has been identified during the manufacturing and the release of this product that could have contributed to the problem reported by the customer.Additionally, no systematic trend of such occurrence has been observed.Therefore, no immediate action is required.
Event or Problem Description
The distal tip of screwdriver broke off while inserting a polyaxial pedicle screw.The broken tip has not been retrieved.It is captured in the screw head inside of the patient without any possibility of migration.Surgery was completed with no further complications.

• Brand Name: ERISMA-LP
• Common Device Name: SCREWDRIVER SHAFT
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 7832086
• Report Number: 3008992889-2018-00001
• Device Sequence Number: 11051684
• Product Code: NKB
• UDI-Device Identifier: 03700780625154
• UDI-Public: (01)03700780625154(10)H224X(11)170321
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: 18911039
• Device Catalogue Number: 18911039
• Device Lot Number: H224X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 111