MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK - IMPLANT

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.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.D1, d4, g1, g4 (510k), h4: this report is for an unknown implant.Part and lot number are unknown.Without the specific part number; the expiration date, udi number, 510-k number, manufacturing site name, and device manufacture date are unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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 report is being filed after the review of the following journal article: tinglin, c.Et al.(2022), inboard stitching bridge technology combined with traditional stitching bridge technology is used in heavy shoulder-sleeve torn shoulder arthroscopy, new medicine, vol.53, no.11, pages 826- 835 (china).The study emphasizes on the effect of the inner anchor stitching bridge technology in combination with the traditional stitching bridge technology in the heavy shoulder sleeve tearing shoulder arthroscopy.The patients evaluated on course of this study: 63 patients the article describes the following procedure: shoulder arthroscopy the devices involved were: unknown implant complications described: 1 unknown patient from the "traditional group" experienced a post-operative infection.It was determined that the reported harms (infection) required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.A copy of this literature article is attached to this medwatch report.

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.Additional narrative: investigation summary- the complaint device was not returned after multiple attempts for device return, 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.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17693022
• MDR Text Key: 322765510
• Report Number: 1221934-2023-03315
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention