MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX TI ANCHR W/OC +NDLS; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222242
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The expiration date is currently unavailable.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 affiliate in (b)(6) that during an arthroscopic rotator cuff repair procedure on an unknown date, it was observed that the 5.5 healix ti anchor w/ orthocord and needles broke when tying the first knot and without pulling too hard.Another like device was used to complete the procedure with a 15 minute delay.There were no fragments generated.There were no 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 provided, it was reported that during a cuff repair procedure while using a 5.5 healix ti anchor w/ orthocord and needles, when tying the first knot and without pulling to hard the sutures broke.No fragments generated.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, visual observations of the photo revealed that the suture was frayed and cut.The photo provide evidence of the failure reported into device, therefore this condition reported can be confirmed.Hands on analysis should provide the evidence necessary to discern a specific root cause, but the device was discarded.Possible hypothesis could be that the user used snaps or other instrument to pull the sutures without wrapping the suture around the snaps creates a stress point on the suture, resulting in breaking it.However, it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device lot number: 6l80735, and no non-conformance's were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthese 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: 5.5 HEALIX TI ANCHR W/OC +NDLS
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11088001
• Report Number: 1221934-2020-04111
• Device Sequence Number: 3561490
• Product Code: HWC
• UDI-Device Identifier: 10886705007882
• UDI-Public: 10886705007882
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,Followup
• Report Date (Section B): 12/12/2020

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 Model Number: 222242
• Device Catalogue Number: 222242
• Device Lot Number: 6L80735
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1