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	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be filed once the analysis is performed.
Event or Problem Description
The surgeon experienced two broken tips on the pedicle screw drivers.One of the tips was broken off in the screw and disposed of with the screw.The tip was retrieved and not left in the patient.The second driver tip was cracked, but not broken off completely.The broken driver occurred at l5-s1 and both breakages were at the same pilot hole.No harm occurred to the patient and the surgery completed without further incident.
Additional Manufacturer Narrative
A follow-up report will be filed once the analysis is performed.12/20/2019 - after analysis using a magnifying glass, it appears a net break of the tip of the shaft.Moreover, it is possible to notice a stop at the opposite of the break point.All striations are in the same direction.This break is characteristic of over-bending by the surgeon.- attachment: [30ra23.Pdf].
Event or Problem Description
The surgeon experienced two broken tips on the pedicle screw drivers.One of the tips was broken off in the screw and disposed of with the screw.The tip was retrieved and not left in the patient.The second driver tip was cracked, but not broken off completely.The broken driver occurred at l5-s1 and both breakages were at the same pilot hole.No harm occurred to the patient and the surgery completed without further incident.

• Brand Name: ERISMA LP
• Common Device Name: SCREWDRIVER SHAFT
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 9786165
• Report Number: 3009962553-2019-00005
• Device Sequence Number: 14077552
• Product Code: HXX
• UDI-Device Identifier: 03700780625154
• UDI-Public: (01)03700780625154
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/19/2019
• Report Date (Section F): 09/06/2019

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: 18911039
• Device Catalogue Number: 18911039
• Device Lot Number: H224X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2019
• Device Age: 29 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/04/2020
• 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