MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH AIM-ARM 125° F/STAT+DYN DIST LOCK ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.037.114

Device Problems Device-Device Incompatibility (2919); Device Difficult to Maintain (3134)

Patient Problem No Code Available (3191)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). It was reported that the guide sleeve could not be disassembled from the aiming arm. The surgery was completed using a different aiming arm of a different angle the investigation could not be completed; no conclusion could be drawn at the time of filing this report. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or 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. Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, a gamma nail open reduction internal fixation (orif) for proximal femoral fracture was performed with proximal femoral nailing system (tfna). During the procedure, the guide sleeve and the aiming arm became unable to be detached. The surgery was completed by using another aiming arm of a different angle and fixed the distal area with the devices. After the surgery, the sales representative confirmed that the sleeve and the arm could be detached. There was no surgical delay and no adverse consequence to the patient. This report is for one (1) aim-arm 125° f/stat+dyn dist lock. This complaint involves two (2) devices. This report is 1 of 2 for (b)(4).

• Brand Name: AIM-ARM 125° F/STAT+DYN DIST LOCK
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA ; 6107195000
• MDR Report Key: 8087204
• MDR Text Key: 127853939
• Report Number: 8030965-2018-58364
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 03.037.114
• Device Lot Number: 9663745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 11/19/2018 Patient Sequence Number: 1