MAUDE Adverse Event Report: DEPUY MITEK LLC US 6.5 HEALIX ADVANCE BR W/OCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 222300

Device Problems Migration or Expulsion of Device (1395); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the affiliate in the (b)(6) that during rotator cuff repair surgical procedure, it was observed that the 6.5 healix advance br w/ocord device was deformed/bent.It was not reported if there was a delay in the surgical procedure, or if a spare device was available for use.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.

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 available for physical evaluation, hence, the complaint cannot be confirmed.Given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, 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 form the affiliate on 01/11/2019 stating that the date of the event was (b)(6) 2018.The adverse event was the implant pulling out from the bone.The affiliate also stated that the case was completed by opening other healix stocks.Additional information received from the affiliate on 01/15/2019 stating that the exact failure that occurred was a deformed implant which occurred intra-op.This event caused a 5 minute surgical delay.There was no patient harm due to this surgical delay.The case was completed by opening another implant which was readily available.The same bone hole was used to complete the procedure and no debris was left in the patient because the device did not break into more than 2 pieces.

• Brand Name: 6.5 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: 8196524
• MDR Text Key: 131493007
• Report Number: 1221934-2018-55830
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705021369
• UDI-Public: 10886705021369
• 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: 12/05/2018

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: 01/31/2019
• Device Catalogue Number: 222300
• Device Lot Number: 3887348
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1