MAUDE Adverse Event Report: SYNTHES GMBH CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 400.834.04S

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2024

Event Type  malfunction  

Event Description

Device report from china reports an event as follows: it was reported that on (b)(6) 2024 that during an unknown surgery, the screw in question broke.While inserting the screw, the surgeon experienced a breakage, all fragments were removed from the patient without additional medical intervention.Another device of the same type was used to complete the procedure.There were no reported adverse patient consequences.This report is for a cranial-scr plusdrive ø1.6 self-drill l4.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is not expected to be returned for manufacturer review/investigation.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.

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.H3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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 history review (dhr): a manufacturing record evaluation was performed for the finished device.Product code # 400.834.04s.Lot # 8017p24.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 13-oct-2023.Manufacturing site: jabil bettlach.Expiry date: 01-oct-2033.Most relevant imdrf annex g code is g07002 (appropriate term/code not available) to capture no findings available due to no product 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.B5: event description updated.

Event Description

There was no surgical delay.

• Brand Name: CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): JABIL BETTLACH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18988613
• MDR Text Key: 338732963
• Report Number: 8030965-2024-04158
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819806511
• UDI-Public: (01)07611819806511
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031807
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.834.04S
• Device Lot Number: 8017P24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1