MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP DHP 2.7/3.5 MED W/EXT LE SHORT 1-; PLATE, FIXATION, BONE

Catalog Number 04.117.701S

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation surgery for the left distal humerus fracture with the plate.During the surgery, the nurse opened the wrong plate (medial plate) by his/her error and the surgeon used the plate because he did not notice that it was the wrong plate.Originally, he wanted to use the lateral plate.On the half of the surgery, the sales rep arrived at the surgery and he found that the fixed plate was the wrong one.The surgeon removed the wrong plate and implanted the correct plate (lateral plate).The surgery was completed successfully with a forty (40) minute delay.This report involves one (1) 2.7mm/3.5mm ti va-lcp ext medl dhp 1h/lt/72mm-short-ster.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: picture review: based on the received pictures there are labels with two different article numbers printed.In addition to the standard labels are there also local labels in japanese language visible, due to the language and as these labels were applied post-manufacturing we can not give any statements about these local labels.The surgical technique guide does provide the required information regarding the lateral (04.117.902) and medial (04.117.701) marking and the lmd shows the correct description on the label.The labels are all correct printed and cannot be confirmed based on the picture, therefore the complaint is rated as not confirmed in the confirmed field.Product was not returned therefore no further investigation possible.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.H3, h4, h6: a device history record (dhr) review was conducted: product code: 04.117.701s.Lot number: 68p5033.Manufacturing site: mezzovico.Release to warehouse date: 15 sep 2020.Expiry date: 01.Sep.2030.A manufacturing record evaluation was performed for the finished device 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: VA-LCP DHP 2.7/3.5 MED W/EXT LE SHORT 1-
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11100396
• MDR Text Key: 234372501
• Report Number: 8030965-2020-10060
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819505698
• UDI-Public: (01)07611819505698
• Combination Product (y/n): N
• PMA/PMN Number: K120070
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.117.701S
• Device Lot Number: 68P5033
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Patient Sequence Number: 1