MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE BR3SUT W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 222296

Device Problems Migration or Expulsion of Device (1395); Failure to Advance (2524)

Patient Problems Injury (2348); Not Applicable (3189); No Code Available (3191)

Event Date 06/03/2019

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.The complaint device is not being returned, 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 on (b)(4) 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

It was reported by the affiliate that during an arthroscopic rotator cuff repair procedure the first 4.5 healix advance three-suture anchor with orthocord was implanted in the posterior medial of the bone head.The surgeon judged that the fixation was incomplete, so a 5.5mm anchor was implanted to the same position.The second 4.5 healix advance three-suture anchor with orthocord was implanted into the anterior medial of the bone head.The implant seemed to be successful; however, the surgeon recognized that the anchor had partially come off from the bone when the surgeon fixed the outside anchor.This anchor was revised to another manufacturer's anchor; however, this revised anchor also came off.The surgeon converted to an open procedure.It was brand new and first use when the issue occurred.There was a sixty minute surgical delay and no harm to the patient.No further information was provided by the hospital.Additional information provided by the affiliate reported that the same bone hole was utilized and the first failed implant was removed from the patient.The affiliate also stated that the devices are not available for evaluation.

• Brand Name: 4.5 HEALIX ADVANCE BR3SUT W/OC
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8757784
• MDR Text Key: 149933407
• Report Number: 1221934-2019-57490
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705021321
• UDI-Public: 10886705021321
• Combination Product (y/n): N
• PMA/PMN Number: K120078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial
• Report Date: 06/03/2019

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: 222296
• Device Lot Number: 2L25195
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR