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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANT
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DEPUY MITEK LLC US UNK - IMPLANT Back to Search Results
Catalog Number UNK - IMPLANT
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2019
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis.Udi: unavailable.Depuy synthes has been informed that the catalog number and lot number are not available.Concomitant medical products: two unknown implant devices.Initial reporter facility name: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
This is report 2 of 3 for the same event.It was reported by the affiliate in (b)(6) that during an arthroscopic shoulder procedure, it was observed that the lupine br ds w/orthcrd device was deformed after opening the packaging.It was reported that two unknown implant devices were opened but had the issue of being deformed.It was reported that another implant device was used to complete the procedure.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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.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.Subsequent follow-up with the customer, additional information was received.It was reported that the event occurred during the arthroscopic repair of labrum injury of shoulder surgery.
 
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.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.H10 additional narrative: investigation summary: according to the information provided, it was reported that the device was deformed when the package was opened.The complaint device is not being returned, multiples attempts for product return were made with no response, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
 
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Brand Name
UNK - IMPLANT
Type of Device
UNK - IMPLANT
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key9488389
MDR Text Key204588592
Report Number1221934-2019-60018
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 11/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK - IMPLANT
Was Device Available for Evaluation? No
Date Manufacturer Received02/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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