MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4.5HLX ADV PK ANC-DYNA STR/BL; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (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.
Event or Problem Description
It was reported by the sales rep in (b)(6) that post-operatively to a rotator cuff repair procedure performed on (b)(6) 2021, it was observed that where they used a 4.5mm healix advance" peek anchor with dynacord" suture device, the patient developed c-acnes infection.The surgeon performed a surgery on (b)(6) 2021 for hardware removal, subscap and rotator cuff re-torn, and shoulder washed-out but elected to not repair.The status of the patient post-surgery was unknown.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: investigation summary : according to the information received, it was reported that post-operatively to a rotator cuff repair where they used three 4.5mm healix advance¿ peek anchor with dynacord¿ suture and two 5.5mm healix advance knotless peek anchor, patient developed c-acnes infection.Surgeon doing surgery to washout and clean infection area.If the implants are loose will remove, however if stable will leave construct and washout shoulder.Infection (hardware removal date for tonight if implant site looks infected) otherwise will do a washout and leave repair.The complaint device is not being returned, therefore unavailable for a physical evaluation.The sterile load information was reviewed to see if there were any other complaints of patient infection for any products sterilized in the same load.There were (b)(4) different lots of product containing (b)(4) devices.A review of the complaint files revealed that no other complaints in which patient infection was reported for a different lot number in the same sterile load.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of (b)(4) devices that were released to distribution.The eto sterilization of the device has been done according to requirements of iso 11135:2014.The certificate of sterilization indicates that the physical acceptance criteria and microbiological acceptance criteria were in compliance with the validated specifications.Upon visual inspection of the photo, it was observed only the labels of the devices reported.The photo do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.A manufacturing record evaluation was also performed for the finished device lot number: 6l37965 and no non-conformance was identified.Based on the results from the sterile load review, sterilization certificate and manufacturing record evaluation, it is unlikely that the reported patient infection was caused by this mitek product.Although it is unlikely that the mitek product was a source of the patient¿s infection, with the information provided, and without the complaint device to evaluate, we cannot determine a definite root cause for the reported event.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: 4.5HLX ADV PK ANC-DYNA STR/BL
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 12019148
• Report Number: 1221934-2021-01906
• Device Sequence Number: 3304358
• Product Code: MBI
• UDI-Device Identifier: 10886705029426
• UDI-Public: 10886705029426
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 222028
• Device Catalogue Number: 222028
• Device Lot Number: 6L37965
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/11/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention