MAUDE Adverse Event Report: SYNTHES HAGENDORF USS REAMER F/PEDICSCR SIDE-OPEN

Catalog Number 388.531

Device Problem Material Discolored (1170)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement.Device is an instrument and is not implanted/explanted.Hospital contact telephone: (b)(6) device is not distributed in the united states, but is similar to device marketed in the usa.Dhr not available as device is older than 10 years.At this time the manufacturing documents for instruments had to be stored for 10 years.Manufacturing location: (b)(4) manufacturing date: 18.Jun.2001.Customer quality evaluation: we have received two articles for investigation, here is the statement: based to the received pictures we do confirming the complaint description.Received condition: 314.750 / 5021 upon visual inspection, the article received is in good condition.The handle is locking bright.No part of the instrument is missing.388.531 / 1090436 upon visual inspection, the article received is in good condition.The cutting edges are used condition.No part of the instrument is missing.Dhr not available as both devices are older than 10 years.At this time the manufacturing documents for instruments had to be stored for 10 years.Tests carried out by an independent laboratory have confirmed that a new canevasit handle, after sterilization is not cytotoxic 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 europe reports an event in (b)(6) as follows: it was reported handle on the hexagonal screwdriver and the reamer for pedicle screws appear to have lost some of their color during the cleaning and sterilization process.When placed on sterile cloths and single use packaging, the cloth and packaging appear contaminated with a brown color similar to the color of the instrument handles.Issue was discovered during the cleaning process, no patient involvement.This report is for one (1) uss reamer for pedicle screws.This is report 2 of 2 for (b)(4).

• Brand Name: USS REAMER F/PEDICSCR SIDE-OPEN
• Type of Device: REAMER
• 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: 6752440
• MDR Text Key: 81385659
• Report Number: 3003875359-2017-10371
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819098176
• UDI-Public: (01)07611819098176(10)1090436
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.531
• Device Lot Number: 1090436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2017
• Initial Date FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2001
• 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