MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINELOOPPLUS ANCHOR W/OC DS; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	210709
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the suture on the lupineloopplus anchor w/oc ds device was broken upon opening its package.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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.
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: the complaint device has not been returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it was observed that the ends of the suture were frayed which indicated broken.Therefore, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number:8l17223, and no nonconformances were identified.A manufacturing investigation was performed; as a result, 100% inspection of the assembly is performed, an in-process control has been performed on 9 parts chosen randomly by a certified operator and were inspected.The result of this process check was successful, none of the 9 parts were non-conformed.There was no need to inspect more parts of the batch nor raise a non-conformance.According to the in-process control.There were controls in place to detect the final conditions of the sutures: control of the assembly of products during production, control of lupine loop products, machine setting for knot production, machine setting node tension, machine adjustment of node cut tension, torque meter settings torque meter setting procedure, knots manufacturing procedure for making knots, cutting and tensioning knots procedure for cutting and tensioning knots, knot/anchor mounting procedure for mounting the knot and anchor, anchor tightening (torque meter) procedure for tightening anchors using the torque meter, procedure for mounting the surgical sutures, winding the surgical sutures on the handle and traying the product, procedure for tensioning the nodes.Based on the above, it is confirmed that the manufacturing process has been performed according to the validated processes.The root cause is not manufacturing related.The results of production controls (100%) and in-process controls (9 samples) are all compliant.The photo do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitkek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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: the device was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, it was observed that the ends of the suture near the anchor were frayed which indicated broken.Therefore, this complaint can be confirmed.The complete packaging of the device was not received; the pouch, the box were missing.A manufacturing record evaluation was performed for the finished device lot number:8l17223, and no nonconformances were identified.A manufacturing investigation was performed; as a result, 100% inspection of the assembly is performed, an in-process control has been performed on 9 parts chosen randomly by a certified operator and have been inspected.The result of this process check was successful, none of the 9 parts were non-conformed.There was no need to inspect more parts of the batch nor raise a non-conformance.According to the in-process control: there are controls in place to detect the final conditions of the sutures: control of the assembly of products during production, control of lupine loop products, machine setting for knot production, machine setting node tension, machine adjustment of node cut tension, torque meter settings torque meter setting procedure, knots manufacturing procedure for making knots, cutting and tensioning knots procedure for cutting and tensioning knots, knot/anchor mounting procedure for mounting the knot and anchor, anchor tightening (torque meter) procedure for tightening anchors using the torque meter, procedure for mounting the surgical sutures, winding the surgical sutures on the handle and traying the product, procedure for tensioning the nodes.Based on the above, it is confirmed that the manufacturing process has been performed according to the validated processes.The root cause is not manufacturing related.The results of production controls (100%) and in-process controls (9 samples) are all compliant.Based on the condition of the device received, we cannot determine a root cause for this failure mode.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitkek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: LUPINELOOPPLUS ANCHOR W/OC DS
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12919971
• Report Number: 1221934-2021-03565
• Device Sequence Number: 12007831
• Product Code: MAI
• UDI-Device Identifier: 10886705001071
• UDI-Public: 10886705001071
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/19/2021

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: 05/31/2024
• Device Model Number: 210709
• Device Catalogue Number: 210709
• Device Lot Number: 8L17223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 01/03/2022; 01/15/2022; 01/21/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/04/2022; 01/18/2022; 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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
• Patient Sex: Unknown