MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN 24 DEGREE PLGA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 228162

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/19/2024

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.H10 additional narrative: e3: reporter is a j&j sales representative.D4: the expiration date is currently unavailable.H4: the device manufacture date is unknown.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported from switzerland that during a meniscal repair surgical procedure it was observed that when the physician attempted to deploy the truespan 24 degree plga anchor device, it was empty.The device did not fire.It was reported that another device was used.There were no adverse consequences to the patient or surgical delay reported.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: 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.

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.H11: additional narrative: d4, h4: the expiration date and device manufacture date were reported as unknown on the initial report; and have been updated accordingly.Therefore, udi: (b)(4).Investigation summary: the product was returned to depuy synthes mitek for evaluation.Depuy synthes mitek then conducted visual inspection and functional test of device received.Visual inspection reveled that the device was returned in used condition and without its packaging and tray, the red trigger was found to be in its full retracted position which means that it was activated.The whit sleeve was removed to identify the presence of the suture and plates, however they were not returned.The rest of the device does not show structural anomalies.To test its functionality, the red trigger was fully squeezed and no anomalies were noted, it was verified that the pusher shaft tip is sliding out completely from the applier needle.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 and have been inspected.The result of this process check is successful, none of the 9 parts were non-conformed.The batch's 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 an empty device for the product has been evaluated by combining probability and severity levels.This risk is acceptable.The analysis showed that the production controls implemented guarantee 100% detection of this type of problem if it was generated in (b)(4).Multiple 100% control, guarantee that this type of defect does not occur in the manufacturing process.We cannot assemble with the type of defect described in the claim.We can conclude that it is highly unlikely that these defects were generated during the manufacturing process.The bounding is limited to this part because the analysis of the complaint shows that there is no other case of defect for these lots.A thorough review of production process controls was conducted.The results show that this batch of product was processed without incident.Nevertheless, there is no evidence of manufacturing anomalies.The root cause is not related to manufacturing.The overall complaint was confirmed as the observed condition of the truespan 24 degree plga would contribute to the complained devices issue.Based on the results of the investigation, and given that the device was returned in used condition, the out of the box failure cannot be substantiated, also there is no enough evidence to adjudicate a root cause for the issue experienced by the customer.Therefore it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: TRUESPAN 24 DEGREE PLGA
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• 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: 18986935
• MDR Text Key: 338734002
• Report Number: 1221934-2024-01010
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026050
• UDI-Public: 10886705026050
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K153667
• 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,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 228162
• Device Lot Number: 220L328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/11/2024; 05/16/2024
• Supplement Dates FDA Received: 04/12/2024; 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2023
• 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