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

Model Number 13911009

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

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 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
• Type of Device: SCREWDRIVER SHAFT
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• Manufacturer (Section G): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• Manufacturer Contact: fadwa bahr ; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 9532954
• MDR Text Key: 198553160
• Report Number: 3009962553-2019-00010
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 03700780627271
• UDI-Public: (01)03700780627271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1