MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 5.5 HEALIX ADVANCE KNTLS BR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222582
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Reporter is company representative.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Hence, this complaint cannot be confirmed.The information provided stated that there was no case involved.However, no further information was 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.(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.
Event or Problem Description
It was reported by the sales rep via phone that during a rotator cuff repair procedure the customer's 5.5 healix advance knotless anchor was broken inside the packaging.The anchor was not used on the patient.The case was completed with another like-anchor with no patient harm or delay.The sales rep was not present and could not specify how the anchor was broken inside the package or any additional information.The device was discarded by the customer.

• Brand Name: 5.5 HEALIX ADVANCE KNTLS BR
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9125452
• Report Number: 1221934-2019-58614
• Device Sequence Number: 2332806
• Product Code: MAI
• UDI-Device Identifier: 10886705030316
• UDI-Public: 10886705030316
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2019

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: 06/30/2021
• Device Catalogue Number: 222582
• Device Lot Number: L946800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 09/26/2019
• Patient Sequence Number: 1