MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4.75 HEALIX ADVANCE KNTLS PEEK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222584
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (l918907), and no non-conformance's 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.Device history lot: a manufacturing record evaluation was performed for the finished device lot number (l918907), and no non-conformance's were identified.
Event or Problem Description
It was reported by the sales rep via phone that during an unknown procedure the 4.75 healix advance knotless peek physically broke during insertion.No fragments were generated.Another device was used to complete the procedure.No patient consequences or surgical delay reported.

• Brand Name: 4.75 HEALIX ADVANCE KNTLS PEEK
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 10190940
• Report Number: 1221934-2020-01625
• Device Sequence Number: 3408427
• Product Code: MBI
• UDI-Device Identifier: 10886705030330
• UDI-Public: 10886705030330
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2020

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 Model Number: 222584
• Device Catalogue Number: 222584
• Device Lot Number: L918907
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/24/2020
• Patient Sequence Number: 1