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

Model Number	222584
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is company representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 that during a rotator cuff repair procedure on (b)(6) 2019, the tip of their 5.5mm healix advance br anchor with dynacord suture cracked during insertion but did not break into two plus piece was still intact.Also, in the same case the tip of their 4.75 healix advance knotless peek anchor cracked when pulling the sutures through which occurred outside the patient.No debris was created in the patient.The procedure was completed with other like devices using the same bone hole with no patient harm or surgical delay to the case.The patient's bone quality was hard.This is report 2 of 2 for (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.One possible root cause could be too many suture tails may have been loaded on the anchor resulting in the anchor cracking from being overloaded.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.No non-conformances were identified for this part-lot number combination per qlik query executed on (b)(6) 2019.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.No nonconformances were identified for this part-lot number combination per qlik query executed on (b)(6) 2019.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.

• Brand Name: 4.75 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: 9323826
• Report Number: 1221934-2019-59532
• Device Sequence Number: 343949
• Product Code: MBI
• UDI-Device Identifier: 10886705030330
• UDI-Public: (01)10886705030330
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: 03/31/2021
• Device Model Number: 222584
• Device Catalogue Number: 222584
• Device Lot Number: L855701
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 11/22/2019
• Patient Sequence Number: 1