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

Model Number	222585
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Hence, this complaint cannot be confirmed.The information provided stated that it was the surgeon's first time using the device, and loaded too many sutures during the procedure.Therefore, the possible root cause of the reported failure can be attributed to user error.Misuse of the device caused the sutures to be stuck in the tunnel.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).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 that during a shoulder procedure when the surgeon was loading the first kite of the 5.5 healix advance knotless peek anchor, he loaded it with too many sutures.When the surgeon went to pull tight the sutures threw the kite, the sutures became stuck in the tunnel.It was the surgeon first time using the device and the issue occurred outside the joint.The procedure was completed by cutting the sutures off the kite and opening a new anchor using the same bone hole.There was no patient consequences or surgical delay to the case.The sales rep stated that the device was discarded by the customer.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: h6: device codes: upon complaint review, it was determined that the device code reported on the initial report was inaccurate.Therefore, the device code has been updated accordingly to reflect the accurate representation of the malfunction.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device history lot = an mre review was performed on product code: 222585.Lot number: l918902; and no anomalies or discrepancies (non-conformance) were found.

• Brand Name: 5.5 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: 9125683
• Report Number: 1221934-2019-58618
• Device Sequence Number: 16727599
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2019

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: 222585
• Device Catalogue Number: 222585
• Device Lot Number: L918902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 11/06/2020; 12/31/2020
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/09/2020; 01/04/2021
• Patient Sequence Number: 1