MAUDE Adverse Event Report: SYNTHES GMBH TAP F/CORTSCR Ø2 L53/24

Catalog Number 311.190

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2013

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: the tap cortex screw became inseparable from the mini quick coupling handle.This is report 1 of 1 for this event (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A review of the device history records was performed and no complaint related issues were found.The investigation could not be completed; no conclusion could be drawn, as no product was received.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device used in a veterinary case.No patient information will be reported.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.Placeholder.

• Brand Name: TAP F/CORTSCR Ø2 L53/24
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436 1938 0; SZ 19380
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3647679
• MDR Text Key: 4183960
• Report Number: 8030965-2014-00401
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 11/07/2013

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: 311.190
• Device Lot Number: 2152100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 02/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1