MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT; CONDYLAR PLATE FIXATION IMPLANT

Catalog Number 02.124.414

Device Problem Break (1069)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that patient underwent revision surgery on (b)(6) 2021 due to broken plate and broken screw.Patient was originally treated for femur fracture on (b)(6) 2020.Ten weeks after the initial surgery, patient began to complaint of pain and intermittent swelling in the thigh.X-ray showed the plate and one screw were broken.This report is for a 4.5mm variable angle locking compression plate (va-lcp) curved condylar plate.This is report 1 of 2 for (b)(4).

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.H10 additional narrative: h3, h6: investigation summary , investigation selection, investigation site: mezzovico, selected flow(s): damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: the returned item was received in mezzovico on february 22nd 2021.Item has been received not in the original packaging.Information etched on it matches to complaint system and dhr.Item is visually bent and broken post-production at level of the holes 5/6/7/8.No evidence of visual non conformance manufacturing related.Dimensional inspection: the returned part was re-inspected for all the features relevant to the complaint condition.The measurable features have been found conforming to manufacturing specifications.No non-conformance manufacturing related identified.Document/specification review: the affected item has been manufactured and then released to warehouse on jun 16, 2020 according to relevant drawing valid from feb 19, 2016.No non-conformances or document change have been identified which may be related to the complaint condition.The involved lot has been manufactured starting from the forging blank art 60067383/ lot 51 p0883.Lri the certificate of the forging blank art 60067383/ lot 51 p0883 it's stated that the material is conforming to specification.Summary: as per selected investigation flow from w-m-8080 appendix a, the investigation performed didn't identify any manufacturing defect or deficiency, thus the complaint investigation is considered as not manufacturing related.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot.M.Franchi: dhr review completed in mez on feb 22, 2021, product code 02.124.414, lot#: 55p3977, manufacturing site: mezzovico , release to warehouse date: jun 16, 2020.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11315303
• MDR Text Key: 231863031
• Report Number: 8030965-2021-00971
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819454101
• UDI-Public: (01)07611819454101
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Date Manufacturer Received: 03/05/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention