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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 Migration (4003)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/14/2022
Event Type  Injury  
Event Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent surgery to treat humerus. The patient did not underwent unreasonable rehabilitation, but cut-out progressed as the patient progressed to 1 to 2 weeks after the initial surgery. According to surgeon the postoperative reduction was good. A revision surgery is not planned. No further information is available. This report is for one (1) 9. 5mm ti multiloc prox humeral nail/lt/cann/160mm-ster. This is report 1 of 7 for complaint (b)(4).
 
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Complainant part is not expected to be returned for manufacturer review/investigation. 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.
 
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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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13764997
MDR Text Key291407612
Report Number8030965-2022-01613
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819431058
UDI-Public(01)07611819431058
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.016.039S
Device Lot Number282P164
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/15/2022 Patient Sequence Number: 1
Treatment
CASQUILLO-CIERRE MULTILOC P/HN/PHN MULTI; LOCKSCR Ø4 L26 F/NAILS TAN DBLUE; LOCKSCR Ø4 L26 F/NAILS TAN DBLUE; TORNILLO MULTILOC Ø4.5 L30 TAN; TORNILLO MULTILOC Ø4.5 L36 TAN; TORNILLO MULTILOC Ø4.5 L38 TAN
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