MAUDE Adverse Event Report: SYNTHES USA DHS®/DCS® GUIDE SHAFT WITH FLATS

Catalog Number 338.23

Device Problems Bent (1059); Material Distortion (2977)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported from the facility regarding the following 4 damaged parts (1 broken, 1 stripped, and 2 metal warped) that were identified in sterile processing.No patient involvement.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4): device is an instrument and is not implanted or explanted.Subject device has been received; no conclusion could be drawn as the product is entering the complaint system.Device 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.

Manufacturer Narrative

The dhs/dcs guide shaft, with flats (part# 338.23) has deformed prongs, the outer diameter at the region of the prongs is now 8.3mm , outside of the specified 7.8mm.The width of the prongs is 2.2mm, less than the 2.5mm called out on the drawing, the coupling screws cannot be inserted smoothly due to the inward bend.This device has likely been damaged due to excessive force during insertion given the deformation pattern of the prongs.The complaint against this part is 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: DHS®/DCS® GUIDE SHAFT WITH FLATS
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4485004
• MDR Text Key: 21560980
• Report Number: 2520274-2015-10766
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1