MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 5.5HLX ADV PK ANC-DYNA 3-SUT; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 222033

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

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

It was reported by a healthcare professional through a review of a clinical research report for clinical evidence on safety and performance of 5.5hlx adv pk anc-dyna 3-sut device that postoperatively to a rotator cuff repair procedure performed on an unknown date in 2019, a patient had a revision 539 days after the initial procedure that included superior capsular reconstruction of the supraspinatus capsule with tensor fascia lata autograft due to supraspinatus tear.According to the report, the patient had loosening of the graft 279 days after the initial procedure.The current status of the patient was unknown.No additional information was provided.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name, and device manufacture date were unknown.Investigation summary: the complaint device is not being returned, it was implanted in the patient, 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's product failure(s).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 to which this complaint is observed in the field.

• Brand Name: 5.5HLX ADV PK ANC-DYNA 3-SUT
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 8472871282
• MDR Report Key: 13970713
• MDR Text Key: 290292165
• Report Number: 1221934-2022-01043
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705029488
• UDI-Public: 10886705029488
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 222033
• Device Catalogue Number: 222033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male