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

Catalog Number 400.834S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Confusion/ Disorientation (2553); Unspecified Tissue Injury (4559)

Event Date 11/01/2023

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.H10 additional narrative: b3: event month and year are known.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10 therapy date: (b)(6) 2021.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 synthes reports an event in china as follows: it was reported that on an unknown date there was mesh breakage post-op.The patient had a cranioplasty procedure on (b)(6) 2021.During a recent examination at the hospital, 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 second operation was necessary.The exact timing for the second surgery has not been determined yet.Currently, the patient is experiencing confusion and is admitted to the hospital.This report involves one (1) ti low profile neuro screw self-drilling 4mm.This is report x of 10 for (b)(4).This product complaint, (b)(4), is related to (b)(4) and (b)(4).Device report from synthes reports an event in china as follows: it was reported that on an unknown date there was mesh breakage post-op.The patient had a cranioplasty procedure on july 20, 2021.During a recent examination at the hospital, 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 second operation was necessary.The exact timing for the second surgery has not been determined yet.Currently, the patient is experiencing confusion and is admitted to the hospital.This report involves one (1) ti low profile neuro screw self-drilling 4mm.This is report 5 of 10 for (b)(4).This product complaint, (b)(4), is related to (b)(4) and (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.H6: device history record (dhr) review conducted: 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.

• Brand Name: TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM
• Type of Device: BONE PLATE
• 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: 18284955
• MDR Text Key: 329960925
• Report Number: 8030965-2023-15476
• 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: 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: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 400.834S
• Device Lot Number: L664904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 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; CRANIAL-SCR PLUSDRIVE ø1.6 SELF-DRILL L4
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 55 KG