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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM TI MATRIXRIB LCKNG SCREW SELF-DRILLING/8MM - STERILE PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM TI MATRIXRIB LCKNG SCREW SELF-DRILLING/8MM - STERILE PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.501.208.01S
Device Problem Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
This report is for an unk - screws: trauma/unknown lot. Part and lot numbers are unknown; udi number is unknown. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; 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
It was reported that during an unknown procedure on (b)(6) 2020, the matrix sub joint screws size 8 mm has pulled off of 2 plates. The reported screws pulled away from the bone. The surgeon decided not to revise issue. It is unknown if there was a surgical delay. There was no patient consequence reported. Surgical outcome is unknown. Concomitant device reported: unknown plated (part # unknown, lot # unknown, quantity 2). This complaint involves 1 device. This is report 1 of 1 for (b)(4).
 
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Brand Name2.7MM TI MATRIXRIB LCKNG SCREW SELF-DRILLING/8MM - STERILE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10106727
MDR Text Key193718384
Report Number2939274-2020-02627
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190409
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.501.208.01S
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 Received06/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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