MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 5.5 HLX ADV BR 2.5 DYNAT BLK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	280736
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Reporter is a j&j sales representative.Investigation summary: the complaint devices are not being returned, they are implanted, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, is showing the loop of suture which should be passing through the holes in the anchor, pulled out, so the anchor broke allowing the suture to separate from it.; therefore, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 7l47939, and no nonconformances were identified.The photo does not provide enough evidence to determine root cause.Without physical evaluation of the device reported, we cannot establish a root cause for the issue experienced by the customer.The possible root cause can be associated with such handling of the device or product interaction during procedure.However, it cannot be conclusively affirmed.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.
Event or Problem Description
This is report 1 of 2 for (b)(4).It was reported by the sales rep that a patient had a rotator cuff repair revision procedure on (b)(6) 2022 as the rotator cuff did not heal.According to the report, there were two medial row anchors in cuff.It was reported that the anchors remained in bone and suture remained in tissue while the knot remained intact and suture knot loop was loose outside of anchor body on both medial row anchors.It was reported that the thought was that the eyelit suture arm bar broke and sutures with knots intact became loose outside of anchor body.The status of the patient was unknown.No additional information was provided.

• Brand Name: 5.5 HLX ADV BR 2.5 DYNAT BLK
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15745492
• Report Number: 1221934-2022-03432
• Device Sequence Number: 20586887
• Product Code: MAI
• UDI-Device Identifier: 10886705031009
• UDI-Public: 10886705031009
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 02/28/2023
• Device Model Number: 280736
• Device Catalogue Number: 280736
• Device Lot Number: 7L47939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female