MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH AIM-ARM 130° F/PFNA BLADE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 356.811

Device Problems Device Damaged Prior to Use (2284); Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product complaint#: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.A review of the device history record.Device history lot: part: 356.811, lot: 2486131, manufacturing site: bettlach, release to warehouse date: 25.May.2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: during a pre surgery check it was noted that the aiming arm is faulty.During blade insertion the aiming arm does not grip properly.The instrument has not been used in a long time.No patient involvement.Concomitant device reported: unknown helical blade (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

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.G5: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h6: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: upon visual inspection of the complaint device, it can be seen that the instrument has a deformation on the section the ¿insertion handle¿ should to bear on flat, but with this damage it is not possible anymore, and this will result in a non-alignment, thus confirming the complaint description.In addition, the instrument is in a very used condition with impression marks and scratches all over, which is an indication of regular use through its more than 10 years of lifespan.Functional test: the relevant features are deformed in a manner which prevents accurate functional test.Furthermore, the investigation has shown that the cause of the complained malfunction is a post-manufacturing caused use-related damage at the device, therefore no functional test is needed.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use-related damage at the device, therefore no dimensional inspection is needed.Document/specification review: drawings and revisions are in accordance to device history review (dhr) of production lot 2486131.All relevant features are defined on the used drawing revisions of dhr of production lot 2486131.Summary: there is no particular information on what's happened to this article by the customer.Unfortunately, we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation, an application error or/and that a cleaning and sterilization error may have taken place.To prevent such problems, it is necessary for worn, incomplete, or damaged instruments to be replaced.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: AIM-ARM 130° F/PFNA BLADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9582558
• MDR Text Key: 190751961
• Report Number: 8030965-2020-00308
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819289994
• UDI-Public: (01)07611819289994
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.811
• Device Lot Number: 2486131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: HELICAL BLADE