MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH BUTTRESS/COMPR-NUT F/PFNA BLADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 356.817

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.No patient information available for reporting.Device is an instrument and is not implanted/explanted.Complaint device is not expected to return.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in (b)(6) as follows: it was reported during a femoral trochanteric fracture repair using the pfna (proximal femoral nail antirotation) system on (b)(6) 2017, the compression nut became stuck to the aiming arm intraoperatively at the end of the procedure.It was noted the surgeon had a difficulty in detaching the compression nut from the aiming arm after use.A surgical delay of 1 minute was noted.No adverse consequence to the patient was reported.(b)(4).

• Brand Name: BUTTRESS/COMPR-NUT F/PFNA BLADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7133593
• MDR Text Key: 95734971
• Report Number: 8030965-2017-50869
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819290013
• UDI-Public: (01)07611819290013(10)LOTNUMBERUNKNOWN
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1