MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM; SCREW, FIXATION, BONE

Catalog Number	04.214.110S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery on (b)(6) 2024, at the time of screw insertion, the screw broke off at the threaded part slightly below the screw head just before the screw head hit the cortex in front of it.The screw was inserted directly, not through the plate, and the torque load was not high.All equipment complied with the specifications.The broken screw was removed, and the surgery was completed successfully with a delay of approximately 20 minutes due to the removal of the plate that had already been installed in order to remove the broken screw.This report involves one 1.5mm ti cortex scr slf-tpng with t4 stardrive recess 10mm.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D2b: additional device product codes: hrs.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.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.H6: imdrf component codes: 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.
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, h6: a manufacturing record evaluation was performed for the finished device.Product code: 04.214.110s-15.Lot:6855p04.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 28 july 2023.Manufacturing site: jabil grenchen.Expiry date: 01 july 2033.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 had broken from the head of the device.The broken fragment was returned for evaluation.The allegation can be confirmed.A dimensional inspection for the device was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the cortscr ã¸1.5 self-tap l10 tan would contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.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.The drawings reflecting the current and manufactured revisions were reviewed.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: 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen CO 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19254831
• Report Number: 8030965-2024-05825
• Device Sequence Number: 15085536
• Product Code: HWC
• UDI-Device Identifier: 10886982120854
• UDI-Public: (01)10886982120854
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.214.110S
• Device Lot Number: 6855P04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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: UNK - DEPTH GAUGES; UNK - DRILL BITS: TRAUMA; UNK - SCREWDRIVERS
• Patient Sex: Unknown