MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX BR 3.4MM; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222343
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4)-incomplete.The lot number is not currently available.
Event or Problem Description
It was reported by the affiliate, that the end of the suture can't get through the lumen of inserter; it doesn't slide.Surgeon has to cut end of suture.It happens regularly.There is no patient consequence.This information being submitted for this complaint are all the details that are known/available regarding this event.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The lot number is currently unavailable; therefore, the expiration date is unavailable.
Event or Problem Description
Additional event information received on 10/18/2018.Reply in the additional event info requested, "re: (b)(4)".
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.Udi:(b)(4).The lot number is not currently available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Evaluation statement: the complaint device was received and evaluated.Visual inspection revealed that the device was missing suture, anchor, handle cover and end of the suture was found cut.Since the suture was cut at the end, the complaint is confirmed.This failure mode results when the suture won't be released completely.Furthermore, no lot number was supplied which precludes conducting a device history record (dhr) review or a lot specific search in the complaints handling system.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 as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).Depuy synthes has been informed that the lot number is not available.
Event or Problem Description
Additional information received from affiliate on 30october2018: the issue was detected during use.It is unknown if there was any difficulty aligning the instruments required for insertion prior to use.It is unknown if excessive force was needed to insert the device.There was no surgical delay.Alternatives were readily available but not used.The procedure was able to be completed and there was no impact to the patient.It is unknown if when the button was depressed and slid forward if the wire advanced as expected or if it retracted when the button was depressed and slid rearward.It is unknown if the wire tip bent or hanging up on the shaft when retracted.It also was not known if the button was easier to move in one direction verse the other.No audible indication of something breaking within the device was heard.No components or pieces broke free from the assembly.

• Brand Name: HEALIX BR 3.4MM
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7874349
• Report Number: 1221934-2018-54639
• Device Sequence Number: 1909269
• Product Code: MAI
• UDI-Device Identifier: 10886705023820
• UDI-Public: 10886705023820
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/15/2018

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 Catalogue Number: 222343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 10/18/2018; 10/30/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/26/2018; 10/30/2018; 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1