MAUDE Adverse Event Report: NOVASTEP AIRLOCK T8 AO SCREWDRIVER TIP

Model Number	AIRLOCK® T8 AO SCREWDRIVER TIP
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Description of the patient and the surgery : no patient's data available no data available concerning the id of the implants used for that surgery the breakage happened "at the end of screwing in".The tip remained "flush in the screw" which means no risk of tissue damage the surgery was performed successfully patient follow-up not determined at this date description of the product : the device is a non-cannulated screwdriver with t8 torx tip.Trackability of the batch: batch number b00104: (b)(4).The responsible device must be one of them, so it is probably on the market since more than 5 years.We can't confirm that it has been used for that period of time.The incident might have happened at its fifth or sixth use only.Verification of the manufacturing record : manufactured in september 2014.No deviation to specifications observed at reception.Review of non-conformities and customer complaints: first occurrence of such a reported defect for that reference.Only 2 non-conformities detected, both due to marking errors, without any link to the current defect.Analysis of product returned: no product returned.Moreover, considering the time of use of the device, the incident doesn't seem to be due to a defective initial design or manufacturing.Thus performing tests or verification on a device from the same batch is not relevant.
Event or Problem Description
Date of incident: (b)(6) 2020.Description: the tip of the screwdriver broke while screwing a locking screw 3.5 (sp0135xx) during the implantation of a lisfranc plate.No explantation required, but the tip could not be removed from the patient's body, it was maintained in the torx footprint.More details received on the 12th of november 2020 : the breakage happened "at the end of screwing in".The tip remained "flush in the screw".The surgery was performed successfully.

• Brand Name: AIRLOCK T8 AO SCREWDRIVER TIP
• Common Device Name: SCREWDRIVER TIP
• Manufacturer (Section D): NOVASTEP; espace performance iii; bâtiment p; saint gregoire, 35769 ; FR 35769
• MDR Report Key: 10911396
• Report Number: 3010673777-2020-00004
• Device Sequence Number: 3006927
• Product Code: HRS
• UDI-Device Identifier: 03700879500980
• UDI-Public: 03700879500980
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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: AIRLOCK® T8 AO SCREWDRIVER TIP
• Device Catalogue Number: XSD02002
• Device Lot Number: B00104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/26/2020
• 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