MAUDE Adverse Event Report: SYNTHES GMBH TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM; PLATE, BONE

Catalog Number	400.834S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Confusion/ Disorientation (2553); Unspecified Tissue Injury (4559)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional 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.B3: event occurred on an unknown date in november of 2023.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10: date of concomitant therapy is (b)(6) 2018.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 or Problem Description
Device report from china reports an event as follows: it was reported that the patient in question had a cranioplasty procedure on (b)(6) 2018.During a recent examination in november of 2023, it was discovered that the titanium mesh used during the surgery had been fractured.This resulted in damage to the scalp and exposure of the implant.As a result, a revision procedure was deemed necessary but has not been scheduled yet.No further information is available.This report is for a ti low profile neuro screw self-drilling 4mm.This is report 7 of 10 for (b)(4).
Additional 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: the device associated with the reported event was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.Based on the investigation findings and the inability to confirm the reported event or draw any conclusions about the root cause, it has been determined that no corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): part# 400.834s, lot # l664904, manufacturing site: werk bettlach, supplier: na, release to warehouse date: 22 nov 2017, expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 or Problem Description
The patient was experiencing confusion and was admitted to the hospital.This report is related to (b)(4), which capture additional impacted products.

• Brand Name: TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM
• Common Device Name: 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: 18310451
• Report Number: 8030965-2023-15580
• Device Sequence Number: 6267141
• Product Code: JEY
• UDI-Device Identifier: 20887587045402
• UDI-Public: (01)20887587045402
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 400.834S
• Device Lot Number: L664904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CRANIAL-SCR PLUSDRIVE ø1.6 SELF-DRILL L4; CRANIAL-SCR PLUSDRIVE ø1.6 SELF-DRILL L4; CRANIAL-SCR PLUSDRIVE ø1.6 SELF-DRILL L4; CRANIAL-SCR PLUSDRIVE ø1.6 SELF-DRILL L4; CRANIAL-SCR PLUSDRIVE ø1.6 SELF-DRILL L4; CRANIAL-SCR PLUSDRIVE ø1.6 SELF-DRILL L4; CRANIAL-SCR PLUSDRIVE ø1.6 SELF-DRILL L4; CRANIAL-SCR PLUSDRIVE ø1.6 SELF-DRILL L4; MATRIXNEURO MESH-PL 200*200 T0.6 CONTOUR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 55 KG