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

Model Number	222005
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
Additional Manufacturer Narrative
Additional narrative: udi: (b)(4).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 left knee performed on (b)(6) 2019 using healix advance br with orthocord, the patient had a revision surgery on (b)(6) 2020 due to a postoperative tendon tear on (b)(6) 2020; and persistent postoperative abnormal or prolonged pain, joint stiffness, and arthrofibrosis on (b)(6) 2020.According to the report, the revision surgery included: rtc revision with regenten patch, distal clavicle excision, lysi of adhesions, labral debridement, sad, and bursectomy.It was further reported that the initial procedures included: rtc repair,biceps tenodesis, and labral debridement.The current status of the patient was unknown.No additional information was provided.
Additional Manufacturer Narrative
Additional narrative: udi: (b)(4).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 left knee performed on (b)(6) 2019 using healix advance br with orthocord, the patient had a revision surgery on (b)(6) 2020 due to a postoperative tendon tear on (b)(6) 2020; and persistent postoperative abnormal or prolonged pain, joint stiffness, and arthrofibrosis on (b)(6) 2020.According to the report, the revision surgery included: rtc revision with regenten patch, distal clavicle excision, lysi of adhesions, labral debridement, sad, and bursectomy.It was further reported that the initial procedures included: rtc repair,biceps tenodesis, and labral debridement.The current status of the patient was unknown.No additional information was provided.
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 left knee performed on (b)(6) 2019 using healix advance br with dynacord, the patient had a revision surgery on (b)(6) 2020 that included: rtc revision with regenten patch, distal clavicle excision, lysis of adhesions, labral debridement, sad, and bursectomy due to a postoperative tendon tear on (b)(6) 2020; and persistent postoperative abnormal or prolonged pain, joint stiffness, and arthrofibrosis on (b)(6) 2020.According to the report, the initial procedure included: rtc repair, biceps tenodesis, and labral debridement.The current status of the patient was unknown.No additional information was provided.

• Brand Name: 5.5HLX ADV BR ANC-DYNA 3-SUT
• 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: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13309410
• Report Number: 1221934-2022-00247
• Device Sequence Number: 17400576
• Product Code: MAI
• UDI-Device Identifier: 10886705029457
• UDI-Public: 10886705029457
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 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: 222005
• Device Catalogue Number: 222005
• 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: 60 YR
• Patient Sex: Female