MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM; SCREW, FIXATION, BONE

Catalog Number	402.880TS
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, the patient underwent an osteosynthesis with a plate for a fracture of left clavicle diaphysis.The surgeon inserted the screw in question to the variable angle (va) locking hole for reduction.The screw head broke off due to over-tightening.The shaft part of the screw was left in the body at the surgeon¿s discretion.Fixation was completed successfully.The surgery was completed successfully with no surgical delay.Patient was stable; there was no patient consequence.This report is for a 2.7mm ti cortex screw slf-tpng with t8 stardrive recess 20mm.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.Additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a synthes employee.H3, h6: a manufacturing record evaluation was performed for the finished device.Product code: 402.880ts.Lot: 5681p29.It was electronically reviewed and no nonconformance's / manufacturing irregularities were identified during the manufacturing process.The product was released on: 12-may-2023, manufacturing site: jabil grenchen, expiry date: 01-may-2028.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.H6 component code: g07002 ¿ device not 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.

• Brand Name: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
• 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 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19750750
• Report Number: 8030965-2024-08770
• Device Sequence Number: 17765137
• Product Code: HWC
• UDI-Device Identifier: 10886982206749
• UDI-Public: (01)10886982206749
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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

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: 402.880TS
• Device Lot Number: 5681P29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2023
• 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: VA-LCP CLAVIC PL 2.7 SHAFT CS3 LE TAN
• Patient Sex: Unknown