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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 85MM STERILE ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 85MM STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.285S
Device Problem Migration (4003)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Nerve Damage (1979); Loss of Range of Motion (2032)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Event year reported as 2018; however, exact date of postoperative helical blade cutout and neck fracture is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. 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 on an unknown date, the patient complained of a restricted range of motion of the hip joint. The facility noted a trochanteric femoral nail advance (tfna) helical blade cut¿out when the patient consulted a surgeon and neck fracture was also confirmed. The patient had an osteosynthesis surgery with a trochanteric femoral nail advance (tfna) on (b)(6) 2018. Just after the surgery, the condition of the affected site was intramedullary type (p type). After the initial surgery, the patient was admitted to an emergency room due to a cranial nerve damage. The surgeon heard that the patient had fallen repeatedly after the surgery and wondered why the femoral neck fracture occurred though the tfna blade had been inserted. Furthermore, the surgeon commented that it was understandable if fracture occurred in other area such as the end of the tfna femoral nail. Reoperation to explant the tfna implants was performed on (b)(6) 2018. The procedure was successfully complete without surgical delay. Patient outcome was unknown and currently, the patient is no longer in the facility. This report captures the post-operative event of helical blade cutout and neck fracture, while related complaint (b)(4) captures the intra-operative issues that occurred during implant removal procedure. Concomitant devices reported: tfna femoral nail (part #: 04. 037. 042s, lot #: h501921, quantity: 1). Unknown locking screw (part #: unknown, lot #: unknown, quantity unknown). This report is for one (1) tfna helical blade 85mm sterile. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameTFNA HELICAL BLADE 85MM STERILE
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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8253758
MDR Text Key133253443
Report Number8030965-2019-59946
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 12/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.285S
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 Received12/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/16/2019 Patient Sequence Number: 1
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