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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONNECT-SCR-CANN F/PFN+PFNA SCREW,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH CONNECT-SCR-CANN F/PFN+PFNA SCREW,FIXATION,BONE Back to Search Results
Catalog Number 357.029
Device Problem Unintended Movement
Event Date 11/30/2018
Event Type  Injury  
Manufacturer Narrative

Initial reporter is synthes sales representative. 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. 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018 during an unknown orthopedic procedure, a proximal femoral nail antirotation (pfna) was inserted. Upon insertion there was difficulty drilling and lining up the guidewire in the middle of the neck. It was noticed that the insertion connecting screw which holds the nail onto the insertion handle had loosened. It was tightened but it was not certain if it was on correctly. It was then reported that the blade did not enter through the nail but posterior to the nail. The nail had to be removed and replaced since the first one was drilled posterior and damaged. Patient consequence was reported as extended time on the operating table under anesthesia. Procedure outcome and patient status are unknown. Concomitant device reported: unknown guidewire (part# 356. 830, lot# unknown, quantity 1). Unknown insertion handles (part# 03. 010. 124, lot# unknown, quantity 1). Unknown drill sleeve (part# 356. 819, lot# unknown, quantity 1). Unknown aim arm (part# 03. 010. 407, lot# unknown, quantity 1). Unknown protection sleeve (part# 356. 818, lot# unknown, quantity 1). Unknown pfna blade (part# unknown, lot# unknown, quantity 1). This report is for one (1) connect-scr-cann f/pfn+pfna. This is report 1 of 1 for (b)(4).

 
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Brand NameCONNECT-SCR-CANN F/PFN+PFNA
Type of DeviceSCREW,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ  2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key8186656
Report Number8030965-2018-59204
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number357.029
Device LOT Number8547027
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/15/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/20/2018 Patient Sequence Number: 1
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