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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 9.5MM TI MULTILOC PROX HUMERAL NAIL/LT/CANN/160MM-STER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 9.5MM TI MULTILOC PROX HUMERAL NAIL/LT/CANN/160MM-STER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.016.039S
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Bone Fracture(s) (1870)
Event Date 02/16/2021
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review investigation. Reporter is a synthes employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 an open reduction internal fixation surgery was performed for two (2) fractures of the left humorous. During the surgery, the surgeon tried to insert the nail without reaming, however he had difficulty inserting it because the medullary cavity was narrower than he'd thought. The devices for reaming had not be prepared so the surgeon inserted the nail by tapping with a hammer and the secondary fracture occurred. The secondary fracture was reduced as much as possible and another nail (8mm diameter) was inserted. The procedure was completed with 60 minutes delay. Concomitant device reported: unk - impaction inst: hammer/mallet: (part# unknown; lot# unknown; quantity: unknown). This report is for one (1) 9. 5mm ti multiloc prox humeral nail/lt/cann/160mm-ster. This is report 1 of 1 for (b)(4).
 
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Brand Name9.5MM TI MULTILOC PROX HUMERAL NAIL/LT/CANN/160MM-STER
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11495400
MDR Text Key253177296
Report Number8030965-2021-02023
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.016.039S
Device Lot Number67P7799
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 Received04/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/05/2020
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: 03/16/2021 Patient Sequence Number: 1
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