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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 130 DEG LCP DHS PLATE-STANDARD BARREL 2 HOLES/60MM-STERILE PLATE,FIXATION,BONE

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SYNTHES GMBH 130 DEG LCP DHS PLATE-STANDARD BARREL 2 HOLES/60MM-STERILE PLATE,FIXATION,BONE Back to Search Results
Catalog Number 02.224.202S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 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 (b)(6) as follows: it was reported that on an unknown date, one (1) dhs plate and one (1) dhs lag screw did not fit together. It is unknown if there was patient or surgical involvement. There is no further information available. This report is for one (1) 130 deg lcp dhs plate-standard barrel 2 holes/60mm-sterile. This is report 1 of 2 for (b)(4).
 
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Brand Name130 DEG LCP DHS PLATE-STANDARD BARREL 2 HOLES/60MM-STERILE
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 Key11976089
MDR Text Key255429711
Report Number8030965-2021-04779
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.224.202S
Device Lot Number90P8537
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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