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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the sales rep in (b)(6) that during an unknown procedure on (b)(6) 2021, it was observed that the tip on the anchor device broke upon insertion at commencement of trying to turn it in.There was no surgical delay or adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: according to the information received, it was reported that during insertion of anchor the tip has broken.Normal by the book insertion technique followed and snap occurred at commencement of trying to turn anchor in.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it was observed that the anchor was broken from the distal part but is held in place by suture; therefore, this complaint can be confirmed.Also, it was identified blood residues along the device.A manufacturing record evaluation was performed for the finished device lot number: 1l85512, and no nonconformances were identified.Further, a review into the mitek complaints system revealed no other complaints for this lot of (b)(4) devices that were released to distribution.No further procedure information was provided to determine at what point in time this failure occurred.We cannot discern a specific root cause for this failure.The possible root cause can be associated with off axis insertion and levering during insertion.However, it cannot be conclusively affirmed.As per ifu, inserting the awl less than the specified depth, axial misalignment or levering with the anchor upon insertion, may result in anchor fracture.Also, it is important to do not apply a bending force to the inserter, this can damage the anchor or inserter tip.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.

• 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: 11455751
• Report Number: 1221934-2021-00816
• Device Sequence Number: 17156008
• 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,Followup
• Report Date (Section B): 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 222304
• Device Catalogue Number: 222304
• Device Lot Number: 1L85512
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1