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

Catalog Number 222295

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Injury (2348); Not Applicable (3189)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported by the affiliate via cst that during a shoulder repair surgery, it occurred a disinsertion of 4.5 healix advance anchor's wire.The procedure was successfully completed by drilling the anchor with no patient consequence, but a delay of 30 minutes reported.There were no fragments generated.

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.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.No nonconformances were identified for this part-lot number combination per qlik query executed 05/30/2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.Udi: (b)(4).

Event Description

Additional information received from the affiliate reported that the patient was young and had good bone quality.It was also reported that an additional bone hole was needed to complete the procedure and that the anchor remained in the patient.The affiliate also reported that normal force was used by the surgeon when the anchor pulled out of the bone and the anchor did not remain on the inserter after removal from the cannula.

• Brand Name: 4.5 HEALIX ADVANCE BR W/OCORD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8605321
• MDR Text Key: 147913954
• Report Number: 1221934-2019-57133
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705021314
• UDI-Public: 10886705021314
• Combination Product (y/n): N
• PMA/PMN Number: K120078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 222295
• Device Lot Number: 2L82283
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 06/17/2019
• Patient Sequence Number: 1
• Patient Age: 45 YR