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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.019.000S
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem Not Applicable (3189)
Event Date 05/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A review of the device history record has been requested. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent osteosynthesis surgery for proximal humeral fracture with the end cap in question. During the end cap insertion, the surgeon tried to insert the end cap a few times, but he couldn't insert it properly. The surgeon finally gave up inserting the end cap because the thread of the end cap was damaged, and he finished the surgery within 30 minutes delay. No further information is available. This report is 1 of 1 for (b)(4).
 
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Brand NameTI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
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 Key10078692
MDR Text Key191685329
Report Number2939274-2020-02477
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
Report Date 05/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.019.000S
Device Lot Number30P7018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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