MAUDE Adverse Event Report: SYNTHES GMBH CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4; PLATE, BONE

Catalog Number 400.834.04S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/29/2022

Event Type  malfunction  

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: complainant part is not expected to be returned for manufacturer review/investigation.Part #: 400.834.04s, lot #: 679p982, manufacturing site: jabil bettlach, release to warehouse date: 03, march 2022, expiry date: 01, february 2032, a manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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 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 china as follows: it was reported that on (b)(6) 2022, during a right supraorbital lateral craniotomy, the screw was broken while screwing in, and the tail end remained in the patient¿s body.The fixation of the titanium plate was continued by screwing in a different a hole.Sixteen screws were used and one was broken.There were no adverse consequences to the patient.No further information is available.This report involves one cranial-scr plusdrive ø1.6 self-drill l4.This is report 1 of 1 for (b)(4).

• Brand Name: CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15529160
• MDR Text Key: 301036582
• Report Number: 8030965-2022-07714
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 679P982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male