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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SALZBURG 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/240MM-STERILE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES SALZBURG 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/240MM-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.019.240S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Undesired Nerve Stimulation (1980); Paralysis (1997)
Event Type  Injury  
Manufacturer Narrative
(b)(4). A revision procedure has not taken place or been scheduled as of yet. The complainant part has not been removed from the patient and, therefore, is not available for evaluation. (b)(6). Investigation could not be completed and no conclusion could be drawn as no device was returned. Device history record review: manufacturing location: (b)(4). Manufacturing date: april 30, 2015 - expiry date: april 1, 2020. Sterilization took place at external supplier in (b)(4). A review of the work order following the sterilization procedure showed that (b)(4) pieces were checked and released for sale. No deviations were noted or non-conformance reports generated. Device 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 experienced post-operative radial nerve paralysis sometime after a surgical procedure performed on (b)(6) 2016 to treat a humeral diaphyseal fracture. At this time, it is unknown if the implant caused the event. The surgeon indicated that there was no reaction to or stimulation from the patient's nerve during the procedure, which involved drilling and screw insertion. The procedure was reportedly completed without complication. However, the surgeon stated that it is possible that the radial nerve was pinched into the fracture site during device repositioning. The surgical assistant further elaborated indicating that the middle oblique hole of the distal fixture was located very close to the radial nerve. Therefore, the radial nerve might have been tucked into the screw head during insertion. The reaction was said to have been around the area of distal fixture, and that the diaphyseal area was not paralyzed. At this time, the patient is recovering and participating in rehabilitation therapy. No plans have been made to remove the implants. (b)(4).
 
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Brand Name8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/240MM-STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES SALZBURG
karolingerstrasse
salzburg 5020
AU 5020
Manufacturer (Section G)
SYNTHES SALZBURG
karolingerstrasse
salzburg 5020
AU 5020
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5755793
MDR Text Key48354447
Report Number3009417901-2016-10020
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK120807
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 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/01/2020
Device Catalogue Number04.019.240S
Device Lot Number5934066
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 Received06/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2015
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: 06/28/2016 Patient Sequence Number: 1
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