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

Model Number	222245
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.One possible root cause is the suture could have been damaged by an instrument being used in the case, resulting in the suture breaking during tensioning.However, without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.No nonconformances were identified for this part-lot number combination.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from mitek colombia reports an event as follows: it was reported by the affiliate via email that during an arthroscopic surgery, two healix ti anchor w/ocord were used.On both occasions the violet threads burst in half at the time of making the knots; it was noted exaggerated force was not used.In this way the repair could only be done with simple points.To conclude the repair, points were made side by side with loose sutures.An additional anchor, which was readily available, was placed in a new bone hole to complete the procedure.No additional intervention is planned.It was noted that an expresswell clamp and open guillotine cutter were used with proper suture management by the surgeon.This report is for a healix anchor.This is report 2 of 2 for (b)(4).

• Brand Name: 5.5 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: 9191111
• Report Number: 1221934-2019-58977
• Device Sequence Number: 3671747
• Product Code: HWC
• UDI-Device Identifier: 10886705007912
• UDI-Public: (01)10886705007912
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K082282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

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 Model Number: 222245
• Device Catalogue Number: 222245
• Device Lot Number: L790145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention