MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4.5 HLX ADV BR 2.5 DYNAT BLK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	280735
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Event or Problem Description
This is report 2 of 2 for (b)(4).It was reported by a healthcare professional through clinical research report for clinical evidence on safety and performance of the healix advance br with dynatape device that postoperatively to a rotator cuff repair procedure performed on (b)(6) 2021, the patient had a revision procedure on (b)(6) 2021 due to a recurrent tear likely secondary to smoking and noncompliance.According to the report, the patient had a postoperative pain and re-tear on (b)(6) 2021.The status of the patient postoperatively was unknown.No additional information was provided.This report is for one (1) 4.5 hlx adv br 2.5 dynat blk device.This complaint involves two (2) devices.
Additional Manufacturer Narrative
Additional narrative: udi: (b)(4).The lot number 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 clinical research data.The clinical research data indicated depuy mitek product failure(s).Since there was no contact information, no follow-up attempts could be performed.It is unknown if complaints derived from this clinical research data 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: 4.5 HLX ADV BR 2.5 DYNAT BLK
• Common Device Name: SOFT-TISSUE ANCHOR, 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 ; 3035526892
• MDR Report Key: 14252884
• Report Number: 1221934-2022-01244
• Device Sequence Number: 5015911
• Product Code: MAI
• UDI-Device Identifier: 10886705031016
• UDI-Public: 10886705031016
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Model Number: 280735
• Device Catalogue Number: 280735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown