MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.084
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.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.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 on an unknown date, during an inspection at the sterile processing department a spiral inserter for spiral blade insertion in an unknown orthokit module was found dirty inside the cannulation.There was no procedure or patient involvement.This report is for one (1) spiral blade inserter for retrograde femoral nails-ex.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Picture review: the narrative could not be confirmed due to the received picture.It is not visible on the photo if the part is dirty.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.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: SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8606100
• Report Number: 8030965-2019-63890
• Device Sequence Number: 2358998
• Product Code: LXH
• UDI-Device Identifier: 07611819784130
• UDI-Public: (01)07611819784130
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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: 03.010.084
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1