MAUDE Adverse Event Report: SYNTHES GMBH TI LOW PROFILE NEURO EMERGENCY SCREW SELF-TAPPING 5MM; PLATE, BONE

Catalog Number 400.855.01C

Device Problem Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2022

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in austria as follows: it was reported that during an unknown procedure on an unknown date in 2022, the surgeon felt that the standard screw and the rescue screw from the implant kit may have been blunt or not self tapping.The tip of the standard screw broke during implantation.There was no surgical delay due to the reported event.There were no patient consequences reported.This report is for one (1) emergscr plusdrive ø1.9 self-tap l5 tan.This is report 2 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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.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

It was further reported that procedure was completed successfully using a backup screw.

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, h6: a manufacturing record evaluation cannot be performed due to lot number being unknown.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 the threads flanks of the cranial-emergscr plusdrive ø1.9 self-tap l5 tan were observed deformed/worn.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A dimensional inspection for the emergscr plusdrive ø1.9 self-tap l5 tan was unable to be performed due to post manufacturing damage.A functional test was unable to be performed since the functionality of the screw cannot be tested with tools.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the emergscr plusdrive ø1.9 self-tap l5 tan would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed the following source controlled drawings were reviewed: -1.9 cranial slf-tap screw cruciform,low profile (current revision) 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 information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI LOW PROFILE NEURO EMERGENCY SCREW SELF-TAPPING 5MM
• Type of Device: PLATE, BONE
• 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15496402
• MDR Text Key: 302935330
• Report Number: 8030965-2022-07460
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819806641
• UDI-Public: (01)07611819806641
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.855.01C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5