MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE KNTLSS PK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222334
Medical Device Problem Codes	Mechanical Jam (2983); Migration (4003)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 rotator cuff repair surgery on an unknown date, it was observed that the 5.5 healix advance kntlss pk device became stuck in the inserter after implanting for a lateral row.Subsequently, the anchor came out while attempting to pull the inserter out.There was a surgical delay of two minutes to complete the surgery with another like device.There were no fragments generated.There were no patient consequences reported.No additional information was provided.
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: correction: g1-2: the manufacturing location has been updated to reflect the correct information.Additional information: 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 (l991807), and no non-conformances 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.

• Brand Name: 5.5 HEALIX ADVANCE KNTLSS PK
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10319982
• Report Number: 1221934-2020-01903
• Device Sequence Number: 14219374
• Product Code: MBI
• UDI-Device Identifier: 10886705023486
• UDI-Public: 10886705023486
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: 07/31/2021
• Device Model Number: 222334
• Device Catalogue Number: 222334
• Device Lot Number: L991807
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 07/30/2020
• Patient Sequence Number: 1