MAUDE Adverse Event Report: SYNTHES GMBH STARDRIVE SCREWDRIVER SHAFT T8 105MM

Model Number 314.467

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  Injury  

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.Additional narrative: event occurred on an unknown date in 2021.Additional procodes: kwq, nkg.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

Device report from portugal reports an event as follows: on an unknown date in 2021, the internal sheath of the screw introducer came broken, which made the surgery impossible.The event had serious consequences because it was verified intraop, with an anesthetized patient.This report is for a stardrive screwdriver shaft t8 105mm.This is report 1 of 1 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.H3, h4, h6: part 314.467, lot 19p4266: manufacturing location: supplier ¿ (b)(4)/ inspected, packaged and released by: monument.Release to warehouse date: january 28, 2020.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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: STARDRIVE SCREWDRIVER SHAFT T8 105MM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16074121
• MDR Text Key: 306407902
• Report Number: 8030965-2022-11675
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819775459
• UDI-Public: 07611819775459
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K192646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 314.467
• Device Catalogue Number: 314.467
• Device Lot Number: 19P4266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other