MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH AIMING ARM ADAPTER FOR HINDFOOT ARTHRODESIS NAIL-EX; GUIDE

Catalog Number	03.008.010
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 (b)(6) reports an event as follows: it was reported on an unknown date that the patient underwent for hindfoot arthrodesis nail procedure.During the surgery, the jig and sleeves were not aligning with the nail and it made difficult to drill through the tibia for the 2 (two) most proximal screws.The drill bit was tapped in with a mallet and screws were firing medial to lateral, there was 25 minutes delay.The surgery was completed successfully.There was no patient consequence.Concomitant device reported: unknown insertion handle (part#: unknown, lot#: unknown, quantity: 1).This complaint involves four (4) devices.This report is for (1) aiming arm adapter for hindfoot arthrodesis nail-ex.This is report 1 of 3 (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: part 03.008.010, lot 8428705: manufacturing site: haegendorf.Release to warehouse date: september 03, 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: many scratches are present all over the device furthermore, due to the severe use, the identification numbers are still visible but slightly faded.Even if the device was clearly used for many times, it still looks able to properly function.Functional tests were performed.The device passed all the tests performed and for this reason the complaint could not be replicated.In order to perform the investigation, the relevant documents, valid when the device was manufactured, have been analyzed.The manufacturing process was executed according to the analyzed documents and no anomalies were identified.According to evidence is not possible to address the final root cause to a manufacturing issue.Most likely a mishandling of the device led to the opening of this complaint.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 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.
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, h6: the device was 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.

• Brand Name: AIMING ARM ADAPTER FOR HINDFOOT ARTHRODESIS NAIL-EX
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10524831
• Report Number: 8030965-2020-06878
• Device Sequence Number: 3118831
• Product Code: FZX
• UDI-Device Identifier: 07611819331082
• UDI-Public: (01)07611819331082
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 08/17/2020

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: 03.008.010
• Device Lot Number: 8428705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 10/22/2020; 11/06/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/26/2020; 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - NAIL INSERTION HANDLES; UNK - NAILS: HINDFOOT ARTHRODESIS NAIL; UNK - SCREWS: LOCKING