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

Catalog Number	222585
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part-lot number combination per qlik query executed on 03/11/2019.No further information regarding the technique or instruments used has been 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.Udi: (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 representative via phone that during a shoulder repair procedure the sales rep's 5.5 healix advance knotless anchor peek first kite was loaded and then while loading the second kite, the surgeon used too many sutures and cracked the anchor.The sales rep stated this occurred outside the patient with no fragments created therefore nothing fell into the patient cavity.The case was completed with another like-anchor with no patient harm or delay.The anchor was discarded by the customer.

• Brand Name: 5.5 HEALIX ADVANCE KNTLS PEEK
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8421413
• Report Number: 1221934-2019-56618
• Device Sequence Number: 19384602
• Product Code: MBI
• UDI-Device Identifier: 10886705030347
• UDI-Public: 10886705030347
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Type of Report: Initial
• Report Date (Section B): 02/20/2019

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: 05/31/2021
• Device Catalogue Number: 222585
• Device Lot Number: L918902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/14/2019
• Patient Sequence Number: 1