MAUDE Adverse Event Report: SYNTHES BETTLACH CHISEL HANDLE; CHISEL, BONE, SURGICAL

Catalog Number 399.540

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device is an instrument and is not implanted/explanted.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Manufacturing location: (b)(4).Manufacturing date: 25july2014.No non-conformance reports 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.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: the screw head broke while using the screwdriver to turn it to lock the chisel blades.There was a surgery prolongation of twenty (20) minutes.This report is for an unknown screw.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Patient condition reported as fine.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Additional narrative: a manufacturing investigation action was conducted/performed.The report indicates that: a dhr review was performed for the affected lot, no abnormalities or deviations were detected, which could lead to the complaint failure.All dimensions and parameters which could lead to the complaint were measured, and fulfill the specifications.Also the hardness of the screw was measured with the result, that it meets the specifications.Based on this the complaint is rated as confirmed but not as valid from the point of view of the manufacturing site.As the part was manufactured according to the specification, mechanical overloading would be most probably root cause for the breakage of the screw.No manufacturing related issue was identified and confirmed, therefore review to the specific prm and prm line is not applicable.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: 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

This report is for a chisel handle.

• Brand Name: CHISEL HANDLE
• Type of Device: CHISEL, BONE, SURGICAL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5083754
• MDR Text Key: 26015567
• Report Number: 9612488-2015-10476
• Device Sequence Number: 1
• Product Code: EML
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 399.540
• Device Lot Number: 9062800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2014
• 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
• Patient Age: 52 YR
• Patient Weight: 58