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

Catalog Number	222308
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The expiration date is unknown.
Event or Problem Description
It was reported by the sales rep via cst that during a shoulder arthroscopy once the 5.5 healix advance peek w/oc&nd was placed in the bone, the specialist used the orthocord suture strands to repair the supraspinatus tendon.While knotting and generating traction to the violet thread, it broke.The traction exerted on the thread was minimal and no deterioration of the strand was observed by manipulation.The repair could be done with the remaining suture thread.The surgery time was not extended due to the incident.There were no consequences for the patient.The specialist affirms that on several occasions the orthocord suture of the anchors breaks easily, something that is not normal.
Additional Manufacturer Narrative
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.Additional narrative: investigation summary the complaint device is not being returned, it is still implanted, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A non-conformance search was performed for this product code 222308, lot #4l53261 combination and no non-conformances were identified.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.Device history no nonconformances were identified for this part number, lot number combination per qlik query executed on (b)(6)2019.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 HEALIX ADVANCE PEEK W/OC&ND
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9113010
• Report Number: 1221934-2019-58491
• Device Sequence Number: 17084404
• Product Code: HWC
• UDI-Device Identifier: 10886705021437
• UDI-Public: 10886705021437
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K120449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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 Catalogue Number: 222308
• Device Lot Number: 4L53261
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 11/11/2019
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 87