MAUDE Adverse Event Report: SYNTHES GMBH CUTTER FOR TI ELASTIC NAILS; INSTRUMENT, CUTTING, ORTHOPEDIC

Catalog Number	359.217
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, that the cutter broke during use.There was no surgical delay.The procedure was completed with another cutter.There was no harm to the patient.This report involves one (1) cutter for ti elastic nails.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: our investigation has shown that the cutter casing is complete broken off.The cutting bolt (inside part) is worn out and the holding pin on the blue handle got popped out.The used condition of the cutting bolt (inside part) indicates that this device was used many times over the years (17 year old).In this relation it can be mentioned that this cutting bolt (359.217.001) is available as spare part.For further information please contact synthes customer service.Further investigation has shown that between shaft handle and the cutter casing was a foreign welding line as well as grinding marks.The complaint condition is confirmed as the cutter casing is complete broken off.The cutting bolt (inside part) is worn out and the holding pin on the blue handle got popped out.This cutter is etched with lot# 1168691 indicating that this part is more than 17 years old.Furthermore the instrument was reworked of a third party company which had the shaft / cutter casing welded as well as grinded.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would have contributed to this complaint condition.Please note; blunt / wear / damage cutting parts require more mechanical power during the application, therefore we recommend that blunt or damaged instruments need to be exchanged before surgery.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot part: 359.217, lot: 1168691, manufacturing site: hägendorf, release to warehouse date: 27.March 2003.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: CUTTER FOR TI ELASTIC NAILS
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10606007
• Report Number: 8030965-2020-07541
• Device Sequence Number: 13751189
• Product Code: HTZ
• UDI-Device Identifier: 07611819096646
• UDI-Public: (01)07611819096646
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 359.217
• Device Lot Number: 1168691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1