MAUDE Adverse Event Report: SYNTHES GMBH 2.4/2.7 TI VA 1ST MTP FSN PL/SM/5 DG/R-S; PLATE, FIXATION, BONE

Catalog Number	04.211.232S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in japan as follows: this pc is related to (b)(4) which reports that the screws broke during the revision surgery.This pc reports that the plate breakage, pain, and faulty union occurred after the primary surgery.It was reported that on (b)(6) 2023, the patient underwent the primary surgery with the mtp fusion plate for the hallux valgus.The surgery was completed successfully without any surgical delay.Plate breakage was confirmed three months after surgery.Then, the patient was being followed up.However, the patient complained of pain and bone fusion has not been achieved.Therefore, the revision surgery was performed on (b)(6) 2023.There are no pieces in the patient.The surgeon confirmed by x-ray.Patient status/ outcome: stable.No further information is available.This report is for one (1) 2.4/2.7 ti va 1st mtp fsn pl/sm/5 dg/r-s.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.H10 additional narrative: d2b: additional product code: hwc.D9: complainant part is not expected to be returned for manufacturer review/investigation.H4, h6 part: 04.211.232s; synthes lot:7873863; supplier lot:n/a; release to warehouse date: feb 06, 2015; manufactured by: synthes elmira; no non conformance reports were generated during production.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: 2.4/2.7 TI VA 1ST MTP FSN PL/SM/5 DG/R-S
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14846
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18210324
• Report Number: 8030965-2023-14852
• Device Sequence Number: 7373133
• Product Code: HRS
• UDI-Device Identifier: 10886982119568
• UDI-Public: (01)10886982119568
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Expiration Date: 01/31/2025
• Device Catalogue Number: 04.211.232S
• Device Lot Number: 7873863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2015
• 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 - SCREWS: TRAUMA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown