MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - INSERTION INSTRUMENT

Catalog Number UNK - INSERTION INSTRUMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number are unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: unknown.(b)(4).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.(b)(4).

Event Description

This is report 1 of 5 for the same event.This report is being filed after the review of the following journal article: dr.Dominik meraner, austria "10 years of arthroscopic latarjet procedure: outcome and complications", indian journal of orthopaedics, volume 53, issue 1, pages 102-110, dr.Dominik meraner, speisinger strasse 109, 1130 vienna, austria.The aim of this study is to evaluate the clinical outcome and complications of the latter procedure, most notably infection rate and nerve damage.Materials and methods: 132 shoulders (106 males/19 females, 68 right/64 left) were included in this retrospective study.Patients were included if treatment was performed for anterior instability and if the patient's instability severity index score was at least 4, or if a revision procedure was performed after a prior unsuccessful arthroscopic or open capsule and labral repair.The devices involved were: depuy mitek latarjet instruments, fms duo, (depuy-synthes), shaver and vapr (depuy-synthes).Complications mentioned in the case report were: hematoma, re-operation, broken k-wire, joint instability.

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
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> the complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.This complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy mitek product failure(s).Multiple attempts were done to obtain more information from the author of the journal article, however, no response was received.It is unknown if complaints derived from this journal article were previously reported and documented in the depuy mitek complaint system at the time of occurrence, as no product code/lot number information was provided to perform the search.Manufacturing record evaluation is not possible due to the lack of product/lot numbers.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.

• Brand Name: UNK - INSERTION INSTRUMENT
• Type of Device: UNK - INSERTION INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9659606
• MDR Text Key: 187760762
• Report Number: 1221934-2020-00418
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - INSERTION INSTRUMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1