MAUDE Adverse Event Report: SYNTHES TUTTLINGEN IN-SITU BENDER; INSTR,BENDING OR CONTOURING

Catalog Number 03.100.090

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on an unknown date the tip from the bender broke.The customer doesn¿t know where the fragment is and when the issue happened.No further information was reported.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/ explanted.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: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Subject device has been received and is currently in the evaluation process.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: an evaluation was performed on the returned device.As per received condition the device; the tip of the article broken off.The complained device has been checked according to the manufacturing and material specifications and it was determined that the requirements and specifications have been fulfilled.Based on this result manufacturing failure can be excluded.The clamp is broken and next to the break deformed also, it shows that excessive force has been applied for a short time, which has led to this damage.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: IN-SITU BENDER
• Type of Device: INSTR,BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; zentraler rechnungseingang; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; zentraler rechnungseingang; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3666865
• MDR Text Key: 4346478
• Report Number: 3009417901-2014-10009
• Device Sequence Number: 1
• Product Code: HXP
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.100.090
• Device Lot Number: T961806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2011
• 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