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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM GAUGE,DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM GAUGE,DEPTH Back to Search Results
Catalog Number 03.019.017
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Reporter is a j&j representative. 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 on (b)(6) 2021, the patient underwent for a procedure. The impactor was coming apart during surgery and the depth gauge was bent, there was no surgical delay. The surgery was completed successfully. The patient outcome was unknown. This complaint involves (2) devices. This report is for (1) depth gauge for multiloc humeral nailing system. This report is 1 of 1 for (b)(4).
 
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Brand NameDEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM
Type of DeviceGAUGE,DEPTH
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES HAEGENDORF GMBH-CN
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13078893
MDR Text Key283671047
Report Number2939274-2021-07215
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.019.017
Device Lot Number65P5484
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2020
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/23/2021 Patient Sequence Number: 1
Treatment
DRIVING CAP
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