MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE KNTLSS PK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222334
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).This report is being filed from the etq complaint management sys preventative actions (capa) ts corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep that during a rotator cuff procedure when loading the suture through the nose of their healix advance knotless peek anchor 5.5mm, the nose of the anchor cracked.The sales rep stated that the device failure occurred before being inserted into the patient.The sales rep reported that the surgeon completed the procedure with another like device using the same bone hole with no patient consequences but there was a two minute delay.The sales rep stated that the device was discarded.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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 of this report.If additional information should become available, a supplemental medwatch will be submitted accordingly.Investigation summary: the device was discarded and therefore, will not be returned for evaluation.A non-conformance was identified for this lot number.The complaint condition is unrelated to the nonconformance.

• Brand Name: 5.5 HEALIX ADVANCE KNTLSS PK
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8264317
• Report Number: 1221934-2018-52472
• Device Sequence Number: 1527184
• Product Code: MBI
• UDI-Device Identifier: 10886705023486
• UDI-Public: 10886705023486
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K130539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2016

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 Expiration Date: 02/28/2019
• Device Catalogue Number: 222334
• Device Lot Number: 3896901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1