MAUDE Adverse Event Report: SYNTHES BETTLACH 5.0MM LOCKING SCREW SELF-TAPPING 55MM; APPLIANCE,FIXATION,NAIL

Catalog Number 213.355

Device Problems Corroded (1131); Pitted (1460); Material Distortion (2977)

Patient Problem Inflammation (1932)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that after removal of the device on (b)(6) 2014, the surgeon noticed traces of erosion (rust) at several locations on the device having entrained inflammation at the patient.The device was implanted (b)(6) 2013; the removal of the implant was programmed.They do not know if there is any patient impact except an inflammatory reaction to the rust.This report is 5 of 8 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Event date: date unknown.Additional product code for this report includes: hwc.Device history records was conducted.The report indicates no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a manufacturing evaluation was completed: all screws are made of stainless steel.The examination of the raw-material inspection sheet of the supplier and the manufacturing documents of the producer showed no deviation in relation to the chemical composition, microstructure and mechanical properties.The material of all of the screws is in compliance with the international standards.The dimensions of the investigated screws (as far as measurable) were checked using a digital sliding caliper and found to be in compliance with the technical drawing of the producer and ao/asif specifications; two screws are not in accordance to the technical drawing of the producer.Corrosion marks (brown film/coat) were observed in several plate holes of the received locking compression plate and on six of the 9 screw heads.The corrosion on the cortex screws results from micromovements between the screw head and the plate.The micromovements cause damage to the passivation layer of the metal and pander crevice corrosion or pitting corrosion.The devices were examined at the brown areas (film/coat) and nearby using the scanning electron microscope (sem) and qualitative energy dispersive x-ray analysis (edx).The brown areas are mainly located on the screw heads.The sem images showed a few areas with pitting on the screw heads.When using the edx analysis several organically residues (human residues and corrosion products) were found.The detected iron and oxygen are an indication of corrosion products (rust).This secondary corrosion is a result of a slight crevice situation between the screw heads and the plate holes in combination with micromovements.The process affects passivation layer of the metal and panders corrosion.Sem observations and findings showed no abnormalities.Based on the results of the qualitative energy dispersive x-ray analysis we can conclude that most of the brown areas are rust and human residues.For metallic implants, especially of implants made of stainless steel it should be noted that several mechanisms can lead to corrosion in the aqueous environments of body fluids.A failure resulting from either material defect or the manufacturing process can be excluded.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.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: 1x art.No.: 213.355, lot 8277298 (screw e), stainless steel.Our investigation shows that there are spotty red areas visible on the plate and screws.The manufacturing review, of all above mentioned articles, shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.We have forwarded the complaint to the rms foundation for a further investigation with the following results: the received devices were implanted on the (b)(6) 2013.According to the device report the retrieval of the devices was planned and performed on (b)(6) 2014.Thereby the surgeon found several locations with traces of corrosion (rust).The corroded devices are suspected to cause an inflammatory reaction to the patient.No further information was available.There was no report with respect to the aftercare of the patient.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.

• Brand Name: 5.0MM LOCKING SCREW SELF-TAPPING 55MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4525269
• MDR Text Key: 5543107
• Report Number: 9612488-2015-10118
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK000682
• 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: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 213.355
• Device Lot Number: 8277298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention