MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP CLAVIC PL 2.7 LAT CS2 LE TAN; PLATE, FIXATION, BONE

Catalog Number	04.112.612S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/29/2023
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 patient underwent orif surgery for distal clavicle fracture with clavicle plate and screws.The surgeon fixed the plate with six distal and four proximal screws.And it was reported that the screw of the distal clavicle plate was broken and was to be removed and replaced with a hook plate.The surgeon commented that it was not caused by the implants because the patient rode a bicycle despite his prohibition and fell, striking his shoulder.X-rays showed that the two most distal row screws were broken off and the plate was dislodged upward from the distal bone fragments.The proximal screws were unchanged.The clavicle plate will be removed on (b)(6) 2023, and revision surgery will be performed with another clavicle plate.The surgery was completed successfully without any surgical delay.Patient status or outcome is stable.No further information is available.This report is for one (1)va-lcp clavic pl 2.7 lat cs2 le tan.This is report 3 of 3 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: d9: complainant part is not expected to be returned for manufacturer review/investigation.Release to warehouse date: (b)(6) 2022.Expiration date: (b)(4) 2032.Part number: 04.112.612s, ti segmental shaft plate lateral/left/medium-sterile.Lot number: 667p951 (sterile).Note: plate was manufactured by elmira; lot number 637p545.Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Supplied was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.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-LCP CLAVIC PL 2.7 LAT CS2 LE TAN
• Common Device Name: PLATE, 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 ; 3035526892
• MDR Report Key: 17128958
• Report Number: 8030965-2023-07466
• Device Sequence Number: 7377494
• Product Code: HRS
• UDI-Device Identifier: 07612334214294
• UDI-Public: (01)07612334214294
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203414
• 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,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 Catalogue Number: 04.112.612S
• Device Lot Number: 667P951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 65 KG