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

Catalog Number 03.113.025

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date component went missing is not known. Device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process. No service history review can be performed as part number 03. 113. 025 with lot number(s) 3665633 is a lot/batch controlled item. The manufacture date of this item is 2-feb-2011. The source of the manufacture date is the release to warehouse date. The service history review is unconfirmed. No ncr's were generated during production that would contribute to the complaint condition. The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition. Manufacturing location: (b)(4). Manufacturing date: 02 february 2011. 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

It is reported the insertion handle is missing the connection screw component. Issue was discovered during inspection of the device. No patient or surgical involvement. This report is for one (1) insertion handle this is report 1 of 1 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was performed on the subject device. The customer reported the connecting screw was missing. The repair technician reported the screw was missing. Missing parts is the reason for repair. The cause of the issue is unknown. The following parts were replaced: m3. 5 screw. The item was repaired per the inspection sheet, passed synthes final inspection on 31-may-2017 and will be returned to the customer upon completion of the service and repair process. The evaluation was confirmed. 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: INSERTN HANDLE F/3.5MM LOW BNDMEDIAL DISTAL TIB PLATE/RIGHT
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6533556
• MDR Text Key: 74060516
• Report Number: 3003875359-2017-10209
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 03.113.025
• Device Lot Number: 3665633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown