MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MULTI HOLE WIRE GUIDE

Catalog Number	03.037.000
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
Initial reporter is synthes sales representative.Device is not expected to be returned for manufacturer review/investigation.Product was not returned.Device history records review could not be completed without lot number.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.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 that on (b)(6) 2019, it was observed in a practical workshop with the proximal femoral nailing system (tfna) team that the central hole of a multi drill sleeve was not permeable to the guide wire.This piece of instruments is essential for orientation in the opening of the medullary canal and is used by some specialists.There was no patient involvement.This report is for one (1) multihole wire guide.This is report 1 of 1 for (b)(4).

• Brand Name: MULTI HOLE WIRE GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8636962
• Report Number: 8030965-2019-64443
• Device Sequence Number: 16740888
• Product Code: FZX
• UDI-Device Identifier: 07611819642270
• UDI-Public: (01)07611819642270
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 04/24/2019

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: 03.037.000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1