MAUDE Adverse Event Report: SYNTHES BETTLACH CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS; EXTRACTOR

Catalog Number 309.530

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2014

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: an evaluation was performed on the returned device.As per received condition of device; the products were not in original packaging, inscription easily readable, scratches visible, toothing completely broken.A check of the hardness was accomplished with hardness tester.The hardness corresponds to specifications.Outer diameter was measured with micrometer gauge.Measure corresponds to specifications.Inner diameter was measured with inner-micrometer.Measure corresponds to specifications.Diameter of borehole was measured with caliper gauge.Measure corresponds to specifications.Length could not be measured due to the damages (broken toothing).The measurement of the toothing cannot be measured either as they are damaged and/or broken.Based on the given information and the results of the investigation, the complaint is confirmed as the alleged failure (broken instrument) could be identified.But the complaint is invalid from a manufacturing standpoint, because the measured parameters fulfill the requirements and no hints for deviations from the required production procedure.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: correction to manufacturing evaluation: products not in original packaging, inscription easily readable, scratches visible, 309.530 thread completely broken.According to the device history records the whole lot was manufactured according to specifications.A check of the hardness was accomplished with hardness tester.The hardness corresponds to specification.The diameter of the shaft was measured with micrometer gauge.Measure corresponds to specifications.Measures of the thread cannot be evaluated as the material is damaged (broken thread).Based on the given information and the results of the investigation, the complaint is confirmed as the alleged failure (broken instrument) could be identified.But the complaint is invalid from a manufacturing standpoint, because the measured parameters fulfill the requirements and the device history record review gave no hints for deviations from the required production procedure.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported when the surgeon removed tomofix plate, he tried to remove the screw with extraction conical, and the instrument broke.The surgeon separated plate with screw head from bone and screw body with chisel.He tried to remove the screw body with reamer tube.Two reamer tubes broke during this procedure.This is report 3 of 4 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.A device history review was conducted.The report indicates that 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.Subject device has been received and is currently in the evaluation process.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

Additional narrative: an investigation summary was performed.The investigation of the complaint articles has shown that: all relevant dimensions were measured and found to be in compliance with specifications.Also measured hardness was confirmed to be in specifications.Also reviewing all device history records shows conformity to the print specifications as well.All lots were released after successful inspection.Therefore, this complaint can be determined as invalid from manufacturing standpoint.We have to assume that the breakages occurred due to mechanical overloading situation during removal procedure.Exceeding applied mechanical force may have caused the breakages.Manufacturing evaluation shows conformity to the specification.Mechanical overloading caused the breakage.No indication for material or design related issue was found.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: CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS
• Type of Device: EXTRACTOR
• 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: 4346147
• MDR Text Key: 13009544
• Report Number: 9612488-2014-10573
• Device Sequence Number: 1
• Product Code: HWB
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/21/2014

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: 309.530
• Device Lot Number: 8960039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/11/2015; 03/17/2015; 03/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2014
• 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