MAUDE Adverse Event Report: CLARIANCE SAS. ERISMA LP; SCREWDRIVER

Model Number	18710024
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/13/2016
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 21 cfr part 803 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 quasi-static overload torsional shear failure starting at the hex lobes and extending to the others hex lobes of the shaft, the potential fracture termination site.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The root cause for the distal tip breaking cannot be positively determined.However, the fracture analysis report suggests that the driver underwent a quasi-static overload torsional shear failure starting at the hex lobes and extending to the others hex lobes of the shaft, the potential fracture termination site.As there has been no issue identified in the manufacturing or release of the device that could have customer and no systemic trends requiring immediate action have been observed.
Event or Problem Description
The distal tip of screwdriver broke off while inserting a polyaxial pedicle screw in the lumbar region of the spine.The broken tip has not been retrieved.It is captured in the screw inside of the patient.Surgery was completed with no further complications.

• Brand Name: ERISMA LP
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): CLARIANCE SAS.; 18 rue robespierre; beaurains, pas de calais 62217 ; FR 62217
• MDR Report Key: 5917907
• Report Number: 3009962553-2016-00001
• Device Sequence Number: 487451
• Product Code: HXX
• UDI-Device Identifier: 03700780623303
• UDI-Public: 03700780623303
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/21/2016

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: 18710024
• Device Catalogue Number: 18710024
• Device Lot Number: G160X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2016
• Initial Report FDA Received Date: 08/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 109