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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.016.035S
Device Problems Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. (b)(4). 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) 2020, the patient underwent the open reduction internal fixation surgery for the proximal humerus fracture. During the nail insertion, it was difficulty to inserting the nail because the medullary cavity was so narrow. Surgeon hammered the nail carefully and inserted the nail. After the nail insertion, when tried to drill to insert the screw, the drill interfered with the nail. The drill bit interfered with the nail on other holes, too. Surgeon found the connection part of the nail had been broken. Surgeon used the philos plate stored in the hospital, and the surgery was completed successfully within 30 minutes delay. The patient conditions was stable. Concomitant device reported: unknown insertion handle (part # unknown, lot # unknown, quantity # 1). This complaint involves three (3) devices. This report is for (1) 8mm ti multiloc prox humeral nail/left/cann/160mm-ster. This report is 1 of 3 for (b)(4).
 
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Brand Name8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER
Type of DeviceROD,FIXATION,INTRAMEDULLARY
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 Key11134269
MDR Text Key230226158
Report Number8030965-2021-00143
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
Type of Report Initial,Followup,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.016.035S
Device Lot Number50P7804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/07/2021 Patient Sequence Number: 1
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