MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE BR W/OC&ND; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222299
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint device was received and evaluated.Only one segment of violet suture was returned.One end of the suture was frayed, indicative of a break, confirming this complaint.The returned segment of suture was tested for straight tensile strength and knot tensile strength using an mts machine.Straight tensile results met the internal design verification specification of average 42lbs (test result = 52lbs) and knot tensile results met the usp requirement specification of average minimum 24lbs (test result = 32lbs).Historically, this failure has been observed when the suture or part of the suture comes in contact with a sharp object; however, a root cause for this specific device failure cannot be conclusively determined.Review of the device history record for the finished goods assembly (p/n 222299) indicated that this batch of (b)(4) devices was processed without incident.Review of the device history record for the violet #2 orthocord suture (component p/n 108149) indicated that this batch of (b)(4) strands was processed without incident.Review of the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices released to distribution.At this 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 to monitor the extent to which this complaint is observed in the field.
Event or Problem Description
It was reported by the affiliate in (b)(4) that during an unspecified surgical procedure, it was observed that one of the orthocord wires of the 5.5 healix advance br w/oc&nd anchor device bustled when the surgeon was suturing the cuff.According to the reporter, the purple suture broke.There was a five minute delay in the surgery to complete the procedure but the surgeon wasn't able to tie the second knot.It was reported that part of the purple suture would be returned as the rest of the anchor got implanted.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 5.5 HEALIX ADVANCE BR W/OC&ND
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8272154
• Report Number: 1221934-2018-53409
• Device Sequence Number: 1448678
• Product Code: MAI
• UDI-Device Identifier: 10886705021352
• UDI-Public: 10886705021352
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K120078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2017

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: 06/30/2018
• Device Catalogue Number: 222299
• Device Lot Number: 3853342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 01/23/2019
• 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: Hospitalization