MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS INSERTION HANDLE F/AIMING A GAUGE,DEPTH

Catalog Number 03.113.025

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reportedly there was no patient involvement. Date of event is unknown. Device is an instrument and is not implanted/explanted. A device history record review was performed for the subject device: part no. : 03. 113. 025; lot no. : l065951; manufacturing location: (b)(4); release to warehouse date: 11. Nov. 2016. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. A product evaluation was performed for the subject device: dhr review: review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Service & repair evaluation: the customer reported the instrument had an unknown issue. 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 9-may-2018 and will be returned to the customer upon completion of the service and repair process. He evaluation was confirmed. The device was deemed serviceable and returned to the customer. No design or manufacturing issues were identified; therefore, it has been determined that no corrective and/or preventative action is proposed. 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 was reported that during service evaluation, the screw of a percutaneous insertion handle for aiming arm (right) was found missing and might require replacement. There was no patient involvement reported. This is report 1 of 1 for (b)(4).

• Brand Name: PERCUTANEOUS INSERTION HANDLE F/AIMING A
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7610733
• Report Number: 2939274-2018-52527
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982072917
• UDI-Public: (01)10886982072917
• 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,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• 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: L065951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown