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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 Off-Label Use (1494)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Complainant device is not expected to be returned for manufacturer review/investigation. (b)(6). Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). Without a lot number the device history records review could not be completed. 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 reports an event in (b)(6) as follows: it was reported that the patient initially went for proximal femoral nail antirotation ii (pfna ii) surgery on (b)(6) 2017. Postoperatively on an unknown date the surgeon noted that the implanted pfna blade was longer than intended. Revision surgery was performed on (b)(6) 2017 and initially implanted pfna blade was replaced with another pfna blade. There was no patient harm or pain reported from the initial blade implantation. Patient status immediately after the event: stable. Concomitant device reported: pfna nail (part # 472. 117s, lo t# unknown, quantity 1), locking bolt (part # 459. 300, lot # unknown, quantity 1). This report addresses the revision due to longer pfna blade. The second revision was performed on (b)(6) 2017 due to backed out blade has been captured under linked complaint com-(b)(4). This report is for one (1) pfna-ii blade l85 tan. This is report 1 of 1 for complaint com-(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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6591316
MDR Text Key75971750
Report Number9612488-2017-10231
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeMY
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 04/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.054S
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 Received04/27/2017
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: 05/25/2017 Patient Sequence Number: 1
Treatment
LOCKING BOLT (PART # 459.300, LOT # UNKNOWN, QTY 1; NAIL (PART # 472.117S, LO T# UNKNOWN, QUANTITY 1)
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