MAUDE Adverse Event Report: SYNTHES GMBH HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED

Catalog Number 03.614.039

Device Problems Compatibility Problem (2960); Material Integrity Problem (2978)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/10/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E1: state (b)(6).E3: reporter is a j&j sales representative.H3, h6: 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 depuy synthes reports an event in japan as follows: it was reported that this was an unknown surgery (c1) performed on (b)(6) 2023.When the surgeon inserted a screw in c1 by the screwdriver, the screwdriver got engaged in the screw.Therefore, the surgeon removed the screw once and exchanged the screwdriver to another one and reinserted the screw again.The reinserted screw is the one that the screwdriver engaged in at first.Between the removal of the screw and reinsertion of the screw, the operation time was extended by approximately 60 minutes and 1,600 ml of blood was lost, affecting the patient.The surgery was completed successfully with about 60 minutes delay.No further information is available.This report is for one (1) hexagonal screwdriver shaft cross pinned.This is report 1 of 2 for complaint (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.The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

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: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the hexagonal screwdriver shaft cross pinned.A dimensional inspection performed for the hexagonal screwdriver shaft cross pinned and met specifications.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the hexagonal screwdriver shaft cross pinned was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot part# 03.614.039 synthes lot # 9982059 supplier lot # 9982059 release to warehouse date: 14 march 2019 supplier: (b)(4) no ncrs were generated during production.Device history review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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: HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED
• 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: 17009206
• MDR Text Key: 315997033
• Report Number: 8030965-2023-06709
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819310612
• UDI-Public: (01)07611819310612
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,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 Catalogue Number: 03.614.039
• Device Lot Number: 9982059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 05/30/2023; 08/09/2023
• Supplement Dates FDA Received: 06/16/2023; 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2019
• 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
• Treatment: HOLD-SL.; OUTERSLEEVE F/HOLDING SLEEVE NO. 03.614.; UNK - SCREWS: SPINE-US.
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female