MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANT; POLYDIOXANONE SUTURE

Catalog Number UNK - IMPLANT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown implant.Part and lot number are unknown.Without the specific part number; the udi number, 510-k number and manufacturing site name are unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

This file is a review of the following journal article: garcía-elvira, r., et al (2020) olecranon mayo iia fractures treated with transosseous high strength suture: a series of 29 cases.Injury, vol.51, pages s94-s102 (spain).The study emphasizes on the assessment of the causes and rates of re-operation in olecranon fractures in adults treated with transosseous suture.The patients evaluated on course of this study: 29 patients the article describes the following procedure: patients who were treated with this transosseous high strength suture between 2010 and 2018.The type of suture used, tourniquet time and surgical time were analyzed for each one.X-rays were taken after 2 weeks, 6 weeks and 6 months, recording complications, causes, rates of re-operation and the final clinical condition.The devices involved was: unknown orthocord.Complications described: ¿two of the three patients (6,8%) required antibiotic and surgical debridement.Removal of sutures was not necessary, since infection affected superficial wound and biofilm was not considered as the infection affected superficial tissues and debridement was performed as soon as acute infection was detected.¿.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the complaint device is not being returned, it was implanted in the patient or availability unknown, 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, 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.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported problem.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.If any additional information is obtained, this complaint will be re-opened to capture that information.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 - IMPLANT
• Type of Device: POLYDIOXANONE SUTURE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12416594
• MDR Text Key: 270859283
• Report Number: 1221934-2021-02619
• Device Sequence Number: 1
• Product Code: NEW
• 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: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - IMPLANT
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention