MAUDE Adverse Event Report: SYNTHES BETTLACH TROCAR FOR CERCLAGE PASSER; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	03.221.003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: no patient involvement.The complaint of separation was received on dec 14, 2016.During the investigation completed on jan 26, 2017, it was found that the device is broken.Additional device product code is fsm.Device is an instrument and is not implanted/explanted.(b)(6).A device history record review was performed for the subject device lot.Manufacturing location: (b)(4), manufacturing date: 28.Sep.2016.No non-conformances 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.A manufacturing investigation was performed for the subject device: trocar (03.221.003 / l133575).Upon visual inspection, the wire of the trocar is broken directly after the handle.The laser marking was readable.The product was returned in a packaging different from the original packaging.A device history record (dhr) review was performed for the affected lot, (b)(4) parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in september 2016.No ncrs were marked in the dhr during production.Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.All dimensions relevant for the function of the product were measured, and fulfill the specifications.The raw material certificate was checked and it was found that all used raw material fulfilled the specifications.Based on this the complaint is confirmed but not valid from the point of view of the manufacturing site.No manufacturing related issue was identified and/or confirmed.The exact reason for this occurrence could not be determined.No product fault could be detected.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
Synthes europe reported an event in (b)(6) as follows: it was reported that the charge nurse was showing staff members how the instrument worked when the shaft of the trocar became separated from the handle of the instrument.It is a new instrument and had not yet been sterilized for use.No adverse event.No patient involvement.This is report number 1 of 1 for complaint (b)(4).

• Brand Name: TROCAR FOR CERCLAGE PASSER
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6358178
• Report Number: 9612488-2017-10073
• Device Sequence Number: 1576996
• Product Code: LXH
• UDI-Device Identifier: 07611819880061
• UDI-Public: (01)07611819880061(10)L133575
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 12/14/2016

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: 03.221.003
• Device Lot Number: L133575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1