MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TAP FOR 3.5MM CORTEX SCREWS/ 50MM CALIBRATION; TAP, BONE

Catalog Number 389.477

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the synapse taps were discovered as no longer being sharp.The procedure was successfully completed.No further information is available.Concomitant devices reported: unknown guide sleeve for tap (part# unknown, lot# unknown, quantity 1), unknown handle with quick coupling (part# unknown, lot# unknown, quantity 1).This report is for one (1) tap for 3.5mm cortex screws/ 50mm calibration.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TAP FOR 3.5MM CORTEX SCREWS/ 50MM CALIBRATION
• Type of Device: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10367787
• MDR Text Key: 201915991
• Report Number: 2939274-2020-03373
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 07611819753105
• UDI-Public: (01)07611819753105
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 389.477
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TAPCORTEX SCREW 3.5 MM L185.; UNK - GUIDES/SLEEVES/AIMING: SPINE.; UNK - HANDLES.