MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HEALIX AV PK 4.5 TAPE WHT/BLUE; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222364
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
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.(b)(4).
Event or Problem Description
It was reported by an affiliate via complaint submission tool online form that when the surgeon was placing the healix anchor into the humerus the tip of it broke.The affiliate reported another healix anchor was used to successfully complete the procedure.It was reported a surgical delay did not occur and fragments were not generated.It was reported surgical intervention was not required and the procedure was successfully completed.
Additional Manufacturer Narrative
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 device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device [l946811] number, and no non-conformances were identified.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.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 [l946811] number, and no non-conformances were identified.
Event or Problem Description
Additional information provided by the affiliate reported the event occurred during a rotator cuff repair procedure and the same bone hole was used to complete the procedure.The affiliate also reported all broken pieces of the device were removed from the patient with graspers.
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.Additional information: (b5) - event description.

• Brand Name: HEALIX AV PK 4.5 TAPE WHT/BLUE
• 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: 9396700
• Report Number: 1221934-2019-59805
• Device Sequence Number: 3096421
• Product Code: MBI
• UDI-Device Identifier: 10886705027842
• UDI-Public: 10886705027842
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2019

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 Model Number: 222364
• Device Catalogue Number: 222364
• Device Lot Number: L946811
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/13/2020; 01/27/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/14/2020; 01/28/2020
• Patient Sequence Number: 1