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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE L80 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE L80 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.280S
Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Device history records review was completed for part# 04. 038. 280s, lot# h201009. Manufacturing location: (b)(4), manufacturing date: oct 05, 2016, expiry date: sep 01, 2026. A review of the device history record revealed no complaint related anomalies. The device history record shows this lot of tfna helical blade 80mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted. This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. This complaint is confirmed based on the review of received x-rays. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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.
 
Manufacturer Narrative
Updated concomitant devices: lot numbers added. 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
Concomitant devices reported: 12mm/125 deg ti cann tfna 170mm - sterile (part # 04. 037. 212s, lot # h027197, quantity 1), ti end cap for tfna 0mm extn - sterile (part # 04. 038. 000s, lot # l312285, quantity 1), 5. 0mm ti locking screw w/t25 stardrive 32mm f/im nail-sterile (part # 04. 005. 522s, lot # l013988, quantity 1).
 
Manufacturer Narrative
Revision surgery was planned for (b)(6) 2017; however it is unknown if the patient revised on (b)(6) 2017 and if the device was explanted. Complainant device is not expected to be returned for manufacturer review/investigation. Medical safety officer reviewed x-rays and complaint description and stated that it appears that the cut-out is isolated to the blade, likely due to poor bone quality and progressive compression of femoral head. The remainder of the construct does not appear to have malfunctioned, nor contributed to the cut-out. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent the original surgery to treat the femoral trochanteric fracture on (b)(6) 2017. X-rays were taken during the healing period, three weeks through two months, after the initial surgery. After observations of the x-rays, it was confirmed that the reduction area had shifted. Cut-out was noticed three months after the surgery. An explant surgery is planned with total hip arthroplasty on (b)(6) 2017. Surgeon commented that the original reduction was the dissection type, which could have been attributable to the shift and the extramedullary type was ideal. Concomitant device reported: 12mm/125 deg ti cann tfna 170mm - sterile (part # 04. 037. 212s, lot # unknown, quantity 1), ti end cap for tfna 0mm extn - sterile (part # 04. 038. 000s, lot # unknown, quantity 1), 5. 0mm ti locking screw w/t25 stardrive 32mm f/im nail-sterile (part # 04. 005. 522s, lot # unknown, quantity 1). This report is for one (1) tfna helical blade 80mm sterile. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameTFNA HELICAL BLADE L80 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7200887
MDR Text Key114564717
Report Number8030965-2018-50432
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.280S
Device Lot NumberH201009
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 Received03/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/17/2018 Patient Sequence Number: 1
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