MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR 12DEG; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 228141

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2023

Event Type  malfunction  

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.Device was used for treatment, not diagnosis.E3: reporter is a j&j sales representative.H4: the device manufacture date is unknown.Udi: (b)(4).Investigation summary: photos were returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photos.Upon visual inspection of the photos, it was observed that the plates were attached to the suture outside of the needle.The suture does not appear to be in its original position around the card.A manufacturing record evaluation was performed for the finished device lot number, and no nonconformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection, this complaint can be confirmed.The manufacturer performed an investigation with the following results: an in process control has been performed on 9 parts chosen randomly by a certified operator as have been inspected.The result of this process check is successful, none of the 9 parts were non-conformed.The batches have been assembled by operators trained and certified on the process validated in production.A training verification has been performed at the moment in the production where the issue could have occurred.Every employee has completed the training for the processes.Effect of having two plates detached for product code 228141 has been evaluated combining probability and severity levels.0 complaints received over 99633 parts produced since 2016 for two plates detached.With a ratio of (b)(4) and is ranking 1 (= improbable and negligeable).This risk is acceptable.7 nr were found during the research between 2016-2024 with the item reference (b)(4) but no nr for the same defect.The analysis showed that the production controls implemented guarantee 100% detection of this type of problem if it was generated in neuchâtel.Multiple 100% control, guarantee that this type of defect does not occur in the manufacturing process.We can conclude that is highly unlikely that these defects were generated during the manufacturing process.We can see that the product has been used.The two plates, its protection and the silicone tube have been removed.For the plates to come out, the product must have been used, removed from its card and repackaged.The root cause is not related to manufacturing.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.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.

Event Description

It was reported by the sales rep in china that during a meniscal repair surgical procedure performed on (b)(6) 2023, when opening the packaging of the omnispan meniscal repair 12deg device it was observed that two plates were detached.It was reported that another like device was used to complete the procedure.There were no adverse consequences to the patient.No additional information could be provided.

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: the investigation has been updated to reflect the correct information: investigation summary according to the information received, it was reported that during the surgery, opened the packing(did not use), noted two plates were detached (as the photo shows).No additional information could be provided.The complaint device was received and evaluated.Upon visual inspection, it was observed that the plates were attached to the suture outside of the needle.The suture does not appear to be in its original position around the card.A manufacturing record evaluation was performed for the finished device lot number: 9l88347, 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 visual inspection, this complaint can be confirmed.The manufacturer performed an investigation with the following results: an in process control has been performed on 9 parts chosen randomly by a certified operator as have been inspected as per wi-ft0118 rev ab.The result of this process check is successful, none of the 9 parts were non-conformed.The batches have been assembled by operators trained and certified on the process validated in production.A training verification has been performed at the moment in the production where the issue could have occurred.Every employee has completed the training for the processes.Effect of having two plates detached for product code 228141 has been evaluated in the wi-6474 rev y by combining probability and severity levels.0 complaints received over 99633 parts produced since 2016 for two plates detached.With a ratio of 0.000 % < 0.02% and is ranking 1 (= improbable and negligible).This risk is acceptable.7 nr were found during the research between 2016-2024 with the item reference 228141 but no nr for the same defect.The analysis showed that the production controls implemented guarantee 100% detection of this type of problem if it was generated in neuchâtel.Multiple 100% control, guarantee that this type of defect does not occur in the manufacturing process.We can conclude that is highly unlikely that these defects were generated during the manufacturing process.We can see that the product has been used.The two plates, its protection and the silicone tube have been removed.For the plates to come out, the product must have been used, removed from its card and repackaged.The root cause is not related to manufacturing.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: OMNISPAN MENISCAL REPAIR 12DEG
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18676851
• MDR Text Key: 335019308
• Report Number: 1221934-2024-00455
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228141
• Device Lot Number: 9L88347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1