MAUDE Adverse Event Report: SYNTHES GMBH TEN Ø2 L440 TAN GREEN

Catalog Number 475.920

Device Problem Human-Device Interface Problem (2949)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: patient was initially implanted with the device in (b)(6) 2013.On (b)(6) 2013 the fracture had healed and the implant was listed for removal on (b)(6) 2014.The patient then fell on the (b)(6) 2014 which caused a fracture and patient was subsequently revised on (b)(6) 2014.X-rays were provided.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Actual event date not known.A review of the device history records was performed and no complaint related issues were found.Subject device has been received and is currently in the evaluation process.Investigation is on going; no conclusion could be drawn.Placeholder.

Manufacturer Narrative

Additional narrative: according to the additional evaluation, the nail was received bent about 70mm above the tip.The relevant dimensions of the received titanium elastic nails were checked and found to be in compliance with the technical drawings and specifications.The examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding material analysis, strength and structural stability.The values were in compliance with the international standard iso.Based on the complaint description we assume that excessive strain resulting of the patients fall has led to re-fracture and the deformation of the nails.No product fault could be detected.Date reported in error.The implant was done in october 2013, but the exact date is not available.

• Brand Name: TEN Ø2 L440 TAN GREEN
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• 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: 3647012
• MDR Text Key: 4287780
• Report Number: 8030965-2014-00372
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K971783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 475.920
• Device Lot Number: 5906516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 02/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2010
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR