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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 NON-LCKNG SCREW SELF-DRILLING/10MM PLATE,FIXATION,BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM TI MATRIXRIB NON-LCKNG SCREW SELF-DRILLING/10MM PLATE,FIXATION,BONE Back to Search Results
Model Number 04.501.250.01
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is 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 synthes reports an event in usa as follows: it was reported that on (b)(6) 2019, the unopened package was received empty. There was no patient involvement. This complaint involves one (1) device. This report is for one (1) 2. 7mm ti matrixrib non-lckng screw self-drilling/10mm. This is report 1 of 1 for (b)(4).

 
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Brand Name2.7MM TI MATRIXRIB NON-LCKNG SCREW SELF-DRILLING/10MM
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 Key9453633
MDR Text Key193928155
Report Number2939274-2019-62636
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
PMA/PMN NumberK190409
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number04.501.250.01
Device Catalogue Number04.501.250.01
Device LOT Number4L53617
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 Received01/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/18/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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