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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/80MM PLATE, FIXATION, BONE

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SYNTHES GMBH 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/80MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.127.180
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

Additional procode: hwc. Reporter is a synthes employee. Part: 02. 127. 180, lot: 45p6759, manufacturing site: (b)(4), release to warehouse date: march 26, 2020. A manufacturing record evaluation was performed for the finished device 02. 127. 180 lot: 45p6759 and no non-conformance's were identified. Based on the information available, it has been determined that no corrective and 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 (b)(6) reports an event as follows: it was reported that on an unknown date, the hospital received an empty package. The package was unbroken but had no screw inside it. This report is for a 3. 5mm variable angle locking screw. This is report 1 of 1 for (b)(4).

 
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Brand Name3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/80MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11131040
MDR Text Key225532772
Report Number8030965-2021-00123
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeNO
PMA/PMN NumberK121601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 12/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number02.127.180
Device LOT Number45P6759
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/21/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/26/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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