MAUDE Adverse Event Report: DEPUY MITEK LLC US 6.5 HEALIX ADVANCE BR3SUT W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222301
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
It was reported by a healthcare professional through clinical research for clinical evidence on safety and performance that postoperatively to an initial procedure of rotator cuff repair surgery of the right knee performed on (b)(6) 2018 using healix advance br with orthocord, the patient had a revision surgery that included reverse total shoulder replacement on (b)(6) 2019 due to persistent pain.According to the report, the patient started experiencing postoperative abnormal or prolonged pain, joint stiffness, neurological complications, and arthrofibrosis on (b)(6) 2018.It was further reported that the initial procedures included: rtc repair, and lysis of adhesions.The current status of the patient was unknown.No additional information was provided.
Additional 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 number was unknown.The lot number was unknown; therefore, the expiration date and manufacture date were unknown.Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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.
Event or Problem Description
It was reported by a healthcare professional through clinical research for clinical evidence on safety and performance that postoperatively to an initial procedure of rotator cuff repair surgery of the right knee performed on (b)(6) 2018 using healix advance br with orthocord, the patient had a revision surgery that included reverse total shoulder replacement on (b)(6) 2019 due to persistent pain.According to the report, the patient started experiencing postoperative abnormal or prolonged pain, joint stiffness, neurological complications, and arthrofibrosis on (b)(6) 2018.It was further reported that the initial procedure included: rtc repair, and lysis of adhesions.The current status of the patient was unknown.No additional information was provided.

• Brand Name: 6.5 HEALIX ADVANCE BR3SUT W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 13309949
• Report Number: 1221934-2022-00255
• Device Sequence Number: 4938257
• Product Code: MAI
• UDI-Device Identifier: 10886705021376
• UDI-Public: 10886705021376
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K120078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Operator of Device: Health Professional
• Device Model Number: 222301
• Device Catalogue Number: 222301
• 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: 06/07/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 01/21/2022
• 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 Age: 55 YR
• Patient Sex: Female