MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX TI ANCHOR W/OCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222253
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
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).Investigation summary: according to the information received, it was reported that when using the ti 4.5 healix anchor, the orthocord suture of the anchor broke at one point and was worn.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it was only observed that a piece of the suture was frayed.The photo do not provide enough evidence to confirm the failure reported.A manufacturing record evaluation was performed for the finished device lot number: 6l28670, and no nonconformances were identified.The photo do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The possible root cause for the reported failure can be attributed to an excessive force applied during the suture threading, as per ifu 109583, apply tension (normal force) on suture lengths.Excessive force may overload the anchor or suture.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 affiliate in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the suture on the anchor on the 4.5 healix ti anchor w/ocord device broke at one point and was worn.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: 4.5 HEALIX TI ANCHOR W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12615425
• Report Number: 1221934-2021-02927
• Device Sequence Number: 17667375
• Product Code: HWC
• UDI-Device Identifier: 10886705007998
• UDI-Public: 10886705007998
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K082282
• 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): 09/28/2021

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: 09/30/2022
• Device Model Number: 222253
• Device Catalogue Number: 222253
• Device Lot Number: 6L28670
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1