MAUDE Adverse Event Report: NOVASTEP NEXIS T25-S 1/4" SCREWDRIVER TIP

Model Number	NEXIS T25-S 1/4" SCREWDRIVER TIP
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Description : nexis t25-s 1/4" screwdriver tip - version a.Batch number : f00037.Lot of xsd06003.Analysis of the batch : 154 parts.State of the stock on (b)(6) 2020: all parts have been put on the market except only one still in stock.No breakage defect on the other parts of this batch.Customer complaint : (b)(4).Investigation : we have conducted a batch file check, an analysis of the material certificate (chemical composition, hardness) and checked the dimensional characteristics of the received piece.The analyses did not show any discrepancy compared to the manufacturing specifications that could generate a particular breakage risk.
Event or Problem Description
Surgery of (b)(6) 2020, (b)(6)." instrument breakage: occurred at the end of the intervention when the surgeon tried to insert a screw head in a cortex.The surgery was carried out correctly except for the implantation of the 3rd screw.This screw has not been inserted enough, which can annoy the patient.The surgeon used another instrument to remove the screw but it was not possible.A follow-up is done to ensure that the full arthrodesis is done.In case of the third screw head is too annoying, a new surgery will be planned for removal of it.Customer complaint : (b)(4).
Additional Manufacturer Narrative
The analysis performed on the breaking area and its shape suggest that the tip was inserted in a depth of 2mm in the screw, although the theoretical max depth is 3.2mm.A control has been performed on 3 screwdrivers of the same batch in association with the reference screw used for the control at arrival.The depth of insertion was between 2.87 and 2.96 mm.These elements do not support the theory telling that the insufficient insertion would be due to a defect of the implied device.The screw being implanted when the incident occurred has been identified.The dhr do not mention any non-conformity in regard to specifications.This suggests that the potential insufficient insertion wouldn't neither be due to a defect of the screw.Patient statement : current patient's state of health: no pain, excellent consolidation - no need to remove the implant.Mdr closed.
Event or Problem Description
Surgery of (b)(6) 2020, (b)(6)." instrument breakage: occurred at the end of the intervention when the surgeon tried to insert a screw head in a cortex.The surgery was carried out correctly except for the implantation of the 3rd screw.This screw has not been inserted enough, which can annoy the patient.The surgeon used another instrument to remove the screw but it was not possible.A follow-up is done to ensure that the full arthrodesis is done.In case of the third screw head is too annoying, a new surgery will be planned for removal of it.Customer complaint : (b)(4).

• Brand Name: NEXIS T25-S 1/4" SCREWDRIVER TIP
• Common Device Name: SCREWDRIVER TIP
• Manufacturer (Section D): NOVASTEP; espace performance iii; bâtiment p; saint-grégoire, 35769 ; FR 35769
• MDR Report Key: 10257363
• Report Number: 3010673777-2020-00001
• Device Sequence Number: 11699552
• Product Code: HWE
• UDI-Device Identifier: 03700879509761
• UDI-Public: 03700879509761
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NEXIS T25-S 1/4" SCREWDRIVER TIP
• Device Catalogue Number: XSD06003
• Device Lot Number: F00037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other