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

Model Number	222582
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review / investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 tip of the customer's 5.5 healix advance knotless br anchor broke when the surgeon tried to pull the sutures through the device.The sales rep stated that the device was never implanted in the patient when the issue occurred therefore no debris in patient.The procedure was completed with another like device with no patient harm or surgical delay to the case.The sales rep stated that the customer discarded the device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # : (b)(4).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.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.Investigation summary: the complaint states that the device is not being returned therefore not available for evaluation, the device was discarded by the customer.We cannot discern a root cause for the reported failure mode.This complaint cannot be confirmed.The lot number was not reported on the complaint for the device, therefore, a qlik query review could not be conducted.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.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).The expiration date is unknown.

• Brand Name: 5.5 HEALIX ADVANCE KNTLS BR
• 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: 8962907
• Report Number: 1221934-2019-58192
• Device Sequence Number: 2418315
• Product Code: MBI
• UDI-Device Identifier: 10886705030316
• UDI-Public: (01)10886705030316
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 08/06/2019

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 Model Number: 222582
• Device Catalogue Number: 222582
• Device Lot Number: L865566
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 10/01/2019
• Patient Sequence Number: 1