MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP DHP 2.7/3.5 DORSO-LAT W/SUPP-LAT PLATE, FIXATION, BONE

Catalog Number 04.117.103S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/29/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022, the patient underwent the osteosynthesis surgery for distal humerus fracture with the plate in question. In the surgery, the locking mechanism of the plate hole did not work normally in the most distal right hole of the plate. Therefore, the plate was replaced with a new one. The surgery was completed successfully with 60 minutes delay. No further information is available. This report is for one (1) va-lcp dhp 2. 7/3. 5 dorso-lat w/supp-lat. This is report 1 of 1 for complaint product complaint (b)(4).

Manufacturer Narrative

Reporter is a j&j employee. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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.

• Brand Name: VA-LCP DHP 2.7/3.5 DORSO-LAT W/SUPP-LAT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES RARON; kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14208715
• MDR Text Key: 290542899
• Report Number: 8030965-2022-02689
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.117.103S
• Device Lot Number: 506P421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• Is the Device Single Use?: Yes

Patient Treatment Data

Date Received: 04/26/2022 Patient Sequence Number: 1

Treatment

UNK - SCREWS: LOCKING