MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 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	02/11/2019
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 investigation summary: the complaint device is not being returned.It was discarded by the customer therefore not available for a physical evaluation.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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).
Event or Problem Description
It was reported by the sales rep via phone that during a shoulder repair procedure the sales rep's 5.5 healix advance knotless peek anchor was being loaded with sutures when the implant cracked.The sales rep stated that the double kites were loaded with too many sutures which caused the implant to crack.The anchor cracked outside the patient, therefore there was no debris created in the patient cavity.The case was completed with another like-anchor with less sutures.There was no patient harm or delay.The sales rep was not present and could not provide any additional information.The device 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 SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8401319
• Report Number: 1221934-2019-56582
• Device Sequence Number: 297735
• 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: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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: 02/13/2019
• Initial Report FDA Received Date: 03/07/2019
• Patient Sequence Number: 1