MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/4H SHAFT/RT-STER PLATE, FIXATION, BONE

Catalog Number 04.111.640S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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 on (b)(6) 2020 the patient underwent surgery for a right distal radius fracture. During the surgery, the surgeon tried to connect the guiding block to the plate, but they couldn¿t be connected completely and there was a gap between the plate and guiding block. They were disconnected once and he turned the screw of the guiding block, but had difficulty in turning the screw. The surgeon tried to connect them again and when he used an unknown screwdriver to connect them, the screw of the guiding block was broken and the fragment remained in the plate. The plate could no longer be used, another plate was used and the surgery was completed successfully with a twenty (20) minute delay. There was no effect to the patient. Concomitant device: unknown screwdriver (part# 03. 111. 600, lot# unknown, quantity 1). This report is for one (1) 2. 4mm ti va-lcp 2-clmn vlr dst rad pl 6h hd/4h shaft/rt-ster. This is report 1 of 2 for (b)(4).

• Brand Name: 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/4H SHAFT/RT-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10862270
• MDR Text Key: 217136260
• Report Number: 8030965-2020-09031
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.111.640S
• Device Lot Number: 63P9796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown