MAUDE Adverse Event Report: SYNTHES HAGENDORF PERIOST-ELEV SLIGHTLY CURV-BLADE STRAIGH; ELEVATOR

Catalog Number 399.480

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a tip of a rasp broke off, there was no reported patient involvement, no reported surgery.The device was found in the sterile processing department, no other information was provided.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is not distributed in the united states, but is similar to device marketed in the usa.Investigation could not be completed and no conclusion could be drawn as no device was received.A review of the device history records was performed and no complaint related issues were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.An evaluation was performed on the returned device.As per received condition the device had a broken and missing tip.The broken surface is homogenous, that indicates good material consistency.During the device history record review it was found that the complained device was manufactured according to the specifications.The lot was produced in 2012.Since the broken tip is missing and no further information was provided, an exact root cause could not be determined.Excessive force may have led to the breakage.No product fault could be detected.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PERIOST-ELEV SLIGHTLY CURV-BLADE STRAIGH
• Type of Device: ELEVATOR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; zentraler rechnungseingang; hagendorf CH46 14; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; zentraler rechnungseingang; hagendorf CH46 14; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3663543
• MDR Text Key: 4341588
• Report Number: 3009417901-2014-10004
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 399.480
• Device Lot Number: 8016692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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