MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCP CLAVICLE PLATE LATERAL/ CS3/ RIGHT/ STERILE; PLATE, FIXATION, BONE

Catalog Number	04.112.615S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
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.Additional narrative: date of event: only the event year is known.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter name and address: initial reporter facility name: (b)(6).Initial reporter occupation: reporter is a j&j employee.Manufacturing location: (b)(4).Release to warehouse date: 28-aug-2021.Expiration date: 01-aug-2031.Part number: 04.112.615s, ti segmental shaft plate lateral/right/large-sterile.Lot number: 342p068 (sterile).Lot quantity: 48.Plate was manufactured by elmira; lot number: 122p502.Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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.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 synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent open reduction/internal fixation for a clavicle fracture with the product in question.Va-clp was used, and the surgery was completed successfully without any surgical delay.After the surgery, the proximal screw broke off.Reoperation was scheduled for on (b)(6) 2022.The surgeon commented ¿i should have chosen one size longer for the plate.Locking was placed near the fracture site, and one fixation was not counted.Patient was working too hard in rehabilitation and moving too often¿.No further information is available.This report involves one2.7mm ti va lcp clavicle plate lateral/ cs3/ right/ sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM TI VA LCP CLAVICLE PLATE LATERAL/ CS3/ RIGHT/ STERILE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16111762
• Report Number: 8030965-2023-00239
• Device Sequence Number: 5753633
• Product Code: HRS
• UDI-Device Identifier: 07612334214331
• UDI-Public: 07612334214331
• 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: 2022
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.112.615S
• Device Lot Number: 342P068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2021
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 85 KG