MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN

Catalog Number	03.010.415
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.We can confirm on the received photos, that the wrong connection screw 03.010.415 was used to fix the two instruments aiming arm aiming arm 03.037.013 and insertion handle 03.037.011.The connecting screw 03.010.415 is intended to fix the instrument 03.010.412 aiming device for guide wire.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 without a lot number the device history records review could not be completed.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 reports an event in (b)(6) as follows: it was reported that during a training session it was noticed that the aiming arm handle cannot be connected to the aiming arm with the connection screw because the provided connection screw is a wrong screw.It is a possible mismatch while assembling the training set.There was no patient involvement reported.This report is for one (1) connecting screw f/guide wire aiming device f/tfn.This is report 3 of 3 for complaint (b)(4).

• Brand Name: CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10617229
• Report Number: 8030965-2020-07640
• Device Sequence Number: 2439667
• Product Code: FZX
• UDI-Device Identifier: 07611819350922
• UDI-Public: (01)07611819350922
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 09/09/2020

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: 03.010.415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1