MAUDE Adverse Event Report: DEPUY MITEK LLC US 6.5 HEALIX ADVANCE KNTLSS PK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a healthcare professional through a review of a clinical research report for clinical evidence on safety and performance of 6.5 healix advance kntlss pk device that postoperatively to a rotator cuff repair procedure performed on an unknown date in 2017, a patient had a reoperation 28 days after the initial procedure due to infection that included irrigation and debridement.According to the report, the patient had an infection, edema and pain postoperatively to the initial procedure.The current status of the patient was unknown.No additional information was provided.
Additional Manufacturer Narrative
Additional narrative: 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: 6.5 HEALIX ADVANCE KNTLSS PK
• Common Device Name: SOFT-TISSUE ANCHOR, NON-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: 13969199
• Report Number: 1221934-2022-01022
• Device Sequence Number: 4882837
• Product Code: MBI
• UDI-Device Identifier: 10886705023431
• UDI-Public: 10886705023431
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: 222335
• Device Catalogue Number: 222335
• 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: 03/17/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/08/2022
• 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: 62 YR
• Patient Sex: Male