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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L95 TAN ROD,FIXATION,INTRAMEDULLARY

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SYNTHES BETTLACH PFNA-II BLADE L95 TAN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.054S
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient¿s initials and weight are not available for reporting. (other number) udi # (b)(4). Complainant part is not expected to be returned. (b)(6). Device is not distributed in the united states. The investigation could not be completed; no conclusion could be drawn, as no product was received. Part number: 04. 027. 054s, synthes lot number: 9659176, release to warehouse date: sep 24, 2015, expiration date: sep 1, 2025, mfg. Site: (b)(4). No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition. 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) is as follows; it was reported that a revision surgery was performed on b)(6) 2016 due to a cutout of a proximal femoral nail antirotation (pfna) blade. The patient was revised to a bipolar hip arthroplasty (bha). The procedure was completed successfully. The patient is doing well. The patient was initially treated on b)(6) 2016 for femur trochanteric fracture with proximal femoral nail antirotation (pfna) and a pfna-blade. The surgeon judged this as jugular base fracture. He completed the surgery but was concerned about unstable rotation so he relieved the rehabilitation after the surgery. Ten (10) days later, the patient transferred to another hospital. Forty (40) days after the surgery, the blade was cutout so the patient returned to the previous hospital. No information regarding the rehabilitation is available. Concomitant devices reported: proximal femoral nail antirotation (part # 472. 105s, lot # 9705665, quantity # 1). This is report number 1 of 1 for b)(4).
 
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Brand NamePFNA-II BLADE L95 TAN
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES BETTLACH
muracherstrasse 3
bettlach CH254 4
SZ CH2544
Manufacturer (Section G)
SYNTHES BETTLACH
muracherstrasse 3
bettlach CH254 4
SZ CH2544
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6141942
MDR Text Key61337569
Report Number9612488-2016-10489
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
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 11/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.054S
Device Lot Number9659176
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 Received11/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2015
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: 12/02/2016 Patient Sequence Number: 1
Treatment
PROXIMAL FEMORAL NAIL ANTIROTATION (PART # 472.105
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