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

Model Number	222334
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by affiliate via complaint submission tool as follows: previous rotator cuff repair.Provisional diagnosis now of infection.All mitek anchors implanted previously at cuff repair removed.Surgeon performed the primary surgery - he believed there was only 4 x mitek anchors implanted, but implant stickers in patient's chart from primary surgery indicate 6 x anchors.Removed 4 x anchors - no other anchors found.Multiple specimens taken.Removed anchors also sent off for microscopy / infection.Devices are retained by 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.B5: subsequent follow-up with the customer, additional information was received.It was reported that the removal surgery was performed on (b)(6) 2020.The status of the patient post-surgery was unknown.The pathology reports of devices sent to their hospital lab to investigate the infection were unknown.D4: the lot number, expiration date, and manufacture date were all reported as unknown on the initial report.All fields have been updated accordingly.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.B2: this field has been updated to reflect the correct information.G1: the manufacturing site name, address, email address and phone number have been updated to reflect the correct information.
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.Investigation summary =according to the information provided, it was reported that on a previous rotator cuff repair.Provisional diagnosis now of infection.All mitek anchors implanted previously at cuff repair removed.Surgeon performed the primary surgery - he believed there was only 4 x mitek anchors implanted, but implant stickers in patient's chart from primary surgery indicate 6 x anchors.Removed 4 x anchors - no other anchors found.Multiple specimens taken.Removed anchors also sent of for microscopy / infection.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, 3 arthroscopy images were provided.Upon visual inspection of the images, it could be observed that there is an anchor with black biological matter in the patients tissue areas more specifically in the bone hole.A manufacturing investigation was performed to retrieve the sterilization information.A manufacturing record evaluation was performed for the finished device 6l63227 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the arthroscopic images provided, this complaint can be confirmed.A possible root cause can be attributed to a physical reaction of the bone/tissue area as per ifu 116034 rev.B adverse effects of absorbable implanted devices include mild inflammatory and foreign body reactions.The sterile load information was reviewed to see if there were any complaints related to infection for any products sterilized in load.There were 22 different lots of product containing 4955 devices.The review of the complaint files revealed there were no complaints in which reported infection for the lot numbers in the sterile load.The eto sterilization of the device has been done according to requirements of iso 11138:2014.The certificate of sterilization indicates that the physical acceptance criteria and microbiological acceptance criteria were in compliance with the validated specifications.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: 5.5 HEALIX ADVANCE KNTLSS PK
• 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: 10962848
• Report Number: 1221934-2020-03810
• Device Sequence Number: 2538779
• Product Code: MBI
• UDI-Device Identifier: 10886705023486
• UDI-Public: 10886705023486
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 222334
• Device Catalogue Number: 222334
• Device Lot Number: 6L63227
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 02/17/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 12/17/2020; 02/17/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR