MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE PEEK W/OC; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222305
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported by the affiliate via phone that during a right rotator cuff repair procedure the 5.5 healix advance peek anchor with orthocord suture loop was broken and could not fix the anchor.Another device was used to complete the surgery.There were no adverse consequences to the patient.The surgery time was not delayed.No additional information could be provided.
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.H10 additional narrative: 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 was received and inspected.A visual inspection was performed to determine if the device had any gross visual defects that may contribute to the complaint condition.However,it is observed that healix advance peek anchor with orthocord suture loop was broken and small broken fragment was observed.Anchor breakages are typically associated with off axis insertion, levering during insertion,hard bone quality or using incorrect instrumentation for preparing bone hole.The possible root cause for the reported failure could be user mishandling.However the definitive root cause cannot be determined.No nonconformances were identified for this part number, lot number combination per qlik query executed on 5/31/2019.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).

• Brand Name: 5.5 HEALIX ADVANCE PEEK W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8735705
• Report Number: 1221934-2019-57441
• Device Sequence Number: 11406151
• Product Code: HWC
• UDI-Device Identifier: 10886705021413
• UDI-Public: 10886705021413
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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: 07/31/2019
• Device Catalogue Number: 222305
• Device Lot Number: 3919778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/19/2019
• Patient Sequence Number: 1