MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI METAPHYSEAL SCR/SLF- TPNG W/T8 STRDRV RECESS/18MM; SCREW, FIXATION, BONE

Model Number	04.118.518
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
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.H10 additional narrative: d2: additional procode: hrs.D9: complainant part is not expected to be returned for manufacturer review/investigation.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 or Problem Description
Device report from switzerland reports, an event as follows: it was reported, that during a procedure on (b)(6) 2023.A 2.7 metaphyseal screw broke while being screwing into the bone (clavicle).The head of the screw snapped off after applying moderate force, and in combination with a variable angle locking compression plate (va-lcp) clavicle hook plate.Procedure was completed successfully with no delay.There was no patient consequence.This report is for a 2.7mm ti metaphyseal scr/slf- tpng w/t8 strdrv recess/18mm.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.H10 additional narrative: d4 part # 04.118.518ts.Lot # 7l66705.Manufacturing site: werk selzach.Release to warehouse date: 09 dec 2020.Expiration date: 01 dec 2025.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 04.118.518.Non-sterile lot # 28p6525.Manufacturing site: 28 nov 2019.Release to warehouse date: werk selzach.Supplier: (b)(4).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 METAPHYSEAL SCR/SLF- TPNG W/T8 STRDRV RECESS/18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17075058
• Report Number: 8030965-2023-07171
• Device Sequence Number: 6738912
• Product Code: HWC
• UDI-Device Identifier: 10886982108821
• UDI-Public: (01)10886982108821
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K120854
• 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 Expiration Date: 12/01/2025
• Device Model Number: 04.118.518
• Device Catalogue Number: 04.118.518TS
• Device Lot Number: 7L66705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/07/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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 - PLATES: VA-LCP.
• Patient Sex: Unknown