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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 11MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH 11MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.037.145S
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 07/01/2018
Event Type  Injury  
Manufacturer Narrative
Patient identifier: (b)(6). Date of device breakage is (b)(6) 2018, exact date is not known. Date of implant reported as (b)(6) 2017, exact date is not known. A review of the device history records has been requested. Subject device has been received and is currently in the evaluation process. 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 europe reports an event in (b)(6) as follows: it was reported patient was implanted with a trochanteric fixation nail advanced (tfna) nail, helical blade, and locking screw in (b)(6) 2017. Patient underwent a revision of the tfna helical blade in (b)(6) 2018 as it was too long. At the same time, the distal locking screw broke but was left implanted. It was reported that at the end of (b)(6) 2018, the tfna nail broke. Patient was returned to surgery on (b)(6) 2018 and revised to a hip prosthesis. Patient status reported as good. The revision of the tfna helical blade in (b)(6) 2018 is addressed in (b)(4). This report addresses the revision due to broken nail. Concomitant devices reported: tfna fenestrated helical blade 85mm (04. 038. 385s, lot h554890, quantity 1), 5. 0mm locking screw with t25 stardrive 36mm for im nails (04. 005. 526, lot l732033, quantity 1). This report is for one (1) 11mm 130 degree cannulated tfna nail 235mm. This is report 1 of 1 for (b)(4).
 
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Brand Name11MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7800761
MDR Text Key117718414
Report Number8030965-2018-55837
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.145S
Device Catalogue Number04.037.145S
Device Lot NumberH483880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/21/2018 Patient Sequence Number: 1
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