MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE PEEK 3SUT W/OC; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: the complaint device is not being returned, it was implanted by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (7l89237), and no non-conformance was identified.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 the sales rep in (b)(6) that during a rotator cuff repair procedure on (b)(6) 2021, it was observed that the suture from 4.5 healix advance peek 3-suture anchor w/ orthocord device snapped when surgeon was attempting to tie sutures.The surgeon pulled out remaining sutures and used a replacement ha anchor instead to complete the procedure with a delay of three minutes.The pc anchor remained in the patient without any sutures and the replacement anchor was placed within close proximity to the original.The device is implanted and not available for evaluation.The status of the patient post-surgery was unknown.No additional information was provided.

• Brand Name: 4.5 HEALIX ADVANCE PEEK 3SUT W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12076254
• Report Number: 1221934-2021-01984
• Device Sequence Number: 11869436
• Product Code: HWC
• UDI-Device Identifier: 10886705021406
• UDI-Public: 10886705021406
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 222304
• Device Catalogue Number: 222304
• Device Lot Number: 7L89237
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention