MAUDE Adverse Event Report: SYNTHES GMBH INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT GAUGE,DEPTH

Catalog Number 03.113.025

Device Problem Device-Device Incompatibility (2919)

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

Event Date 12/05/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during an lcp medial distal tibia internal fixation with jig procedure, the aiming arm and insertion handle did not align with lcp holes. The surgeon was unable to use these instruments for percutaneous insertion. There was no surgical delay. The procedure was successfully completed. There was no patient consequence. Concomitant device reported: unknown tibial plate (part # unknown, lot # unknown, quantity unknown). This report is for one (1) insertn handle f/3. 5mm low bnd medial distal tib plate/right. This is report 2 of 2 for (b)(4).

• Brand Name: INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11102229
• MDR Text Key: 224599626
• Report Number: 8030965-2020-10084
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• 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: 12/05/2020

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

• Device Catalogue Number: 03.113.025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/31/2020 Patient Sequence Number: 1

Treatment

PERCUTANEOUS AIMING ARM R F/LCP MED DIST; UNK - PLATES: 3.5MM LCP MEDIAL DISTAL TIBIA PLATE