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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOHMANN RETRACTOR 15MM 160MM
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOHMANN RETRACTOR 15MM 160MM Back to Search Results
Model Number 399.49
Device Problems Retraction Problem (1536); Device-Device Incompatibility (2919); Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2022
Event Type  malfunction  
Event Description
Device report from synthes reports an event in canada as follows: it was reported that on february 28, 2022, the four (4) lobster claw ratchets from the instrument tray did not stay shut.The baby homen tips were both straight and not retracting properly.This report involves one (1) hohmann retractor 15mm 160mm.This is report 2 of 4 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: medical device problem code.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.
 
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Brand Name
HOHMANN RETRACTOR 15MM 160MM
Type of Device
RETRACTOR
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM   78532
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13938067
MDR Text Key296750420
Report Number2939274-2022-01102
Device Sequence Number1
Product Code GAD
UDI-Device Identifier10886982202864
UDI-Public(01)10886982202864
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,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 Received03/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number399.49
Device Catalogue Number399.49
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
BONE LEVER, WIDTH 15 MM, LENGTH 160 MM; BONE LEVER, WIDTH 15 MM, LENGTH 160 MM; BONE LEVER, WIDTH 15 MM, LENGTH 160 MM; REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM; REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
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