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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL N/A

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SYNTHES USA AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL N/A Back to Search Results
Catalog Number 03.019.008
Device Problem Failure to Align (2522)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 11/17/2016
Event Type  malfunction  
Manufacturer Narrative
Device used for treatment, not diagnosis. Additional narrative: (b)(4). Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history record review and the investigation could not be performed; no conclusion could be drawn, as no product was received, therefore, a dhr-review not possible due to the missing lot number. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the devices were used in surgery for the proximal humeral fractures on (b)(6) 2016. The interference checkup in the dry condition was not performed. When the surgeon was trying the distal side stoppage, the drill interfered with the nail. So he moved on to the drilling of the proximal side stoppage. Then, he re-tried the distal side stoppage, but he could not succeed. He preliminarily drilled the distal side with k-wires. Finally, he succeeded drilling and penetrated without the drill sleeve. This complaint involves 1 part. There is no information available about patient and surgical outcome. There was a surgical prolongation of 5 minutes reported. Concomitant devices: 1x 04. 016. 035s / (b)(4) (multiloc phn ø8 le cann l160 tan); 2x 03. 010. 060 / unk (drill bit ø3. 2 calibr l340 3flute f/03. 0); 2x 03. 010. 063 / unk (protect sleeve 12/8 l188); 2x 03. 010. 064 / unk (protect sleeve 12/8 l188); 1x 03. 019. 006 / unk (insert-handle f/multiloc hum nail syst); 1x 03. 019. 007 / unk (connecscr cann f/multiloc hum nail syst). This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
(b)(4). Device 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.
 
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Brand NameAIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL
Type of DeviceN/A
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6159298
MDR Text Key62370858
Report Number2520274-2016-15646
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.019.008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/09/2016 Patient Sequence Number: 1
Treatment
1X 03.019.006, UNK (INSERT-HANDLE F/MULTILOC HUM N; 1X 03.019.007, UNK (CONNECSCR CANN F/MULTILOC HUM; 1X 04.016.035S, (MULTILOC PHN Ø8 LE CANN L160 TAN); 2X 03.010.060, (DRILL BIT Ø3.2 CALIBR L340 3FLUTE; 2X 03.010.063, UNK (PROTECT SLEEVE 12/8 L188); 2X 03.010.064, UNK (PROTECT SLEEVE 12/8 L188)
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