MAUDE Adverse Event Report: SYNTHES BETTLACH SURELOCK CONNECTOR-LEFT ANTEGRADE FEMORAL NAILS; GUIDE

Catalog Number	03.010.201
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Reporter phone number is not provided for reporting.A device history record (dhr) review was performed for part # 03.010.201, lot # 2757873: manufacturing location: (b)(4), manufacturing date: 19.Jul.2011: no non-conformance reports (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.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 europe reports an event in (b)(6) as follows: it was reported that the reported device was used in the surgery for the femoral trochanteric fracture on (b)(6) 2017.The tfna nail (long) was used for the procedure.When the surgeon tried to drill the hole for the distal locking screw by using the surelock aiming arm for antegrade femoral nails, the drill bit interfered with the nail.It was found that the connecting part of the surelock aiming arm to the handle had been loose.One of the three projected parts on the aiming arm, which were all supposed to be fixed usually, had not been fixed (it was recessed).The surgery was extended for sixty (60) minutes.No adverse consequence to the patient was reported, procedure was successfully completed.Concomitant device: tfna nail long (quantity 1), drill bit (quantity 1).This report is for one (1) surelock connector-left antegrade femoral nails.This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
A manufacturing investigation action & summary was conducted/performed.The report indicates that: 1x article 03.010.201 lot 2757873 / forwarded to manufacturing plant bettlach: as received condition of device: product not received in the original packaging.The laser marking was not easy to read, because of repeated use.The surface shows heavy signs of wear and the flat surface shows damages.Dhr review were performed, no abnormalities / deviations, neither ncs were detected, which could lead to the complaint failure.The components 50114275 and 50114274 are purchasing parts therefore no dhrs were performed for these components, no dhrs are available.As relevant for the complaint condition the features which are marked yellow and which have contact with the related products were identified and checked.The part was manufactured in 2011 and showed heavy traces of repeated use.Due to repeated use, the product is visibly worn and therefore several measured parameters do not conform to the specification.The product was manufactured and tested according to the requirements in 2011.All measured dimensions at this time fulfilled the requirements.The complaint part is composed of the subcomponents.There is no functional test available for the failure reported in the complaint condition, not all involved articles for the malfunction were returned to the manufacturing site, the complaint failure could not be reproduced.Therefore, the complaint is rated as not determinable.As described above the product is worn from repeated use which leads to the fact that not all dimensions fulfilled the requirements.Based on the performed investigations there is no indication of a failure in manufacturing which could lead to the complaint issue.Therefore, the complaint is rated ¿not valid¿.The product is worn out - which is most probably the cause of the failure - and should not be used anymore.Since no manufacturing issue was identified and complaint is not valid, review for the specific prm and pra 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.

• Brand Name: SURELOCK CONNECTOR-LEFT ANTEGRADE FEMORAL NAILS
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 7034489
• Report Number: 9612488-2017-10586
• Device Sequence Number: 799454
• Product Code: FZX
• UDI-Device Identifier: 07611819880887
• UDI-Public: (01)07611819880887(10)2757873
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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: 03.010.201
• Device Lot Number: 2757873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR