MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - FLUID MANAGEMENT

Catalog Number UNK - FLUID MANAGEMENT

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

Patient Problem Tissue Damage (2104)

Event Date 01/01/2016

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.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 report is being filed after the review of the following journal article: patrick vavken, md, msc, switzerland "first 50 pediatric and adolescent elbow arthroscopies: analysis of indications and complications", pediatric orthopaedics volume 36, number 4, june 2016, patrick vakven, md, msc, division of sports medicine, boston children¿s hospital, harvard medical school, 319 longwood avenue, boston, ma 02115.E-mail: patrick.Vavken@childrens.Harvard.Edu.This study focuses on the indications and complications of the first 50 elbow arthroscopies in skeletally immature patients done in a specialized pediatric orthopaedic department.A total of 26 boys and 24 girls with a mean age of 13.6 ± 3.3 years at the time of surgery and a minimum follow-up of 1 year were included.Fifty-eight percent were treated for osteochondritis dissecans, 24% for arthrofibrosis, 14% for a congenital disorder, and 4% for a posttraumatic problem other than arthrofibrosis.The complication rate was 8%, including 3 cases of transient neuropraxia and 1 superficial wound infection.There were no major complications such as septic arthritis, vascular injury, or permanent nerve damage.All complications resolved fully with conservative treatment, no revision were required.The devices involved were: fms duo; depuy mitek inc., raynham, ma complications mentioned in the case report were: soft tissue injury (b)(6) year old, male patient.(b)(4).Soft tissue injury (b)(6) year-old female.Soft tissue injury (b)(6) year-old female.Infection (b)(6) year old.

Manufacturer Narrative

Product complaint #
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> pc-(b)(4).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 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.Udi:unavailable the udi is unknown.

• Brand Name: UNK - FLUID MANAGEMENT
• Type of Device: UNK - FLUID MANAGEMENT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9659855
• MDR Text Key: 186405630
• Report Number: 1221934-2020-00431
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• 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 - FLUID MANAGEMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR