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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA BLADE PERF L105 TAN ROD,FIXATION,INTRAMEDULLARY

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SYNTHES BETTLACH PFNA BLADE PERF L105 TAN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.036S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: patient weight is not available for reporting. Date of event is unknown. (b)(4). (therapy date): unknown. Device is not expected to be returned for manufacturer review/investigation. (b)(6). Unknown, device is not distributed in the united states, but is similar to device marketed in the usa. A device history record review was completed for part # 04. 027. 036s, lot # 9752030: manufacturing location: (b)(4), manufacturing date: 09-dec-2015, expiry date: 01-dec-2025: no non-conformance reports (ncrs) were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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 europe reports an event in (b)(6) as follows: it was reported that a proximal femoral nail antirotation (pfna) blade and nail removal surgery was performed on (b)(6) 2016 due to a collapsed femoral head. A total hip replacement was performed. Patient outcome was reported to be good. Concomitant device reported as: 4. 9mm ti locking bolt 36mm (part # 459. 360, lot # unknown, quantity 1). This is report 2 of 2 for (b)(4).
 
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Brand NamePFNA BLADE PERF L105 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 Key6181304
MDR Text Key62596065
Report Number9612488-2016-10514
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
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 11/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.027.036S
Device Lot Number9752030
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 Received11/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2015
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: 12/16/2016 Patient Sequence Number: 1
Treatment
ONE (1) 4.9MM TI LOCKING BOLT 36MM (459.360)
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