MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN; SCREW, FIXATION, BONE

Model Number	04.211.018
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the 49-year-old male patient underwent the unknown surgery for clavicle trunk fracture with va clavicle.The fracture site was slightly distal and was a wedge-shaped fracture with a range of 3 cm.The fracture was wrapped with thread, repaired, and fixed with cs1 for the diaphysis.Posterior therapy was limited to 90° abduction elevation.On (b)(6) 2023, 9 days after surgery, the most proximal screw was found to be broken off at the neck.The fracture site appears to be slightly displaced from the initial fixation due to the breakage of one screw.Both distal and proximal are fixed with four va2.7 locking screws each, but the proximal one or two appear to be hanging on the fracture on the x-ray, and the surgeon was concerned about it.His comment on the relationship between this event and the product is that the major cause of the breakage may be the lack of strength of the 2.7mm diameter.He considered choosing a plate one size longer intraoperatively, but chose cs1 because the plate did not hit well in templating.The reoperation was not considered at this point.The fracture site is slightly displaced, but it is difficult to determine if it is considered a health hazard at this time.There has been no indication so far from the surgeon that the slight dislocation has increased pain.No further information is available.This report is for one (1) va lockscr ã¸2.7 he 2.4 self-tap l18 tan.This is report 1 of 1 for complaint (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: additional product code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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.
Additional Manufacturer Narrative
Nthes 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.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: VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN
• Common Device Name: SCREW, FIXATION, 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 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16408507
• Report Number: 8030965-2023-02047
• Device Sequence Number: 14892791
• Product Code: HWC
• UDI-Device Identifier: 10886982119018
• UDI-Public: (01)10886982119018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.211.018
• Device Catalogue Number: 04.211.018TS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male