MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN 12 DEGREE PEEK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 228151

Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/19/2023

Event Type  malfunction  

Event Description

It was reported from the affiliate in poland that during an unspecified surgical procedure on (b)(6) 23, the truespan 12 degree peek device, when sewing the medial tissue and pressing the trigger, the fixation implant did not leave the guide (it stuck at the end) as a result, the tissue was traumatized.Another like device was used to complete the procedure.There was no delay in the procedure reported.No additional information was 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: e3: reporter is a j&j sales representative.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.

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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted 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 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.H10 additional narrative: visual inspection revealed that the two implants were deployed.There are no anomalies or structural damage on the outside of the device.It was verified that the pusher shaft tip is sliding out completely the applier needle, no obstruction or difficulties while actioned.A manufacturing record evaluation was performed for the finished device, and no non conformances were identified.Based on the meniscal repair technique guide, it is necessary to choose the portal which most easily allows the delivery needle to be inserted perpendicular to the tear site; as a recommendation when performing, an anterior meniscal repair, it is advised to use an angled truespan device to maximize your ability to reach and position your anterior meniscal repair site.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: TRUESPAN 12 DEGREE PEEK
• 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: 17932255
• MDR Text Key: 326190806
• Report Number: 1221934-2023-03735
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: 10886705026012
• Combination Product (y/n): N
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228151
• Device Lot Number: 129L019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1