MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228151

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter phone number (b)(6).Udi: (b)(4).

Event Description

It was reported by the affiliate via email that during an unknown procedure the deployment of two truespans degree peek guns failed.Also, the trigger of the second device seemed to snap and was stuck inwards after the first deployment.The suture also didn¿t come out with the gun after the first fire for both occasions.The surgeon seemed to do everything as per the instructions for use in both occasions.He used a 24 degree truespan prior which worked fine however it was two 12 degree needles that failed dot deploy properly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.B5: subsequent follow-up with the customer, additional information was received.It was reported that the event occurred during arthroscopic meniscal repair of the knee joint.It was reported that there was surgical delay of about 20 minutes while they had to open sets for another competitor product and also collect the anchor that had been deployed by truespan.It was reported that the user had to physically remove failed anchor from the meniscus (as it was also peek and non-absorbable) both times causing stress and procedural time wasted.It was reported that the case was completed eventually using smith and nephew fastfix after the two failed truespan deployments.It was reported that there were no patient consequences but also caused stressed to the user.It was reported that an alternative product was readily available - fastfix.It was reported that there was no surgical intervention planned (e.G.X-rays, additional/change in procedures, prescriptions, otc, revisions).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: additional information: investigation summary
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> the complaint device is not being returned, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (l705467), and no non-conformances were identified.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.Device history lot
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> a manufacturing record evaluation was performed for the finished device lot number (l705467), and no non-conformances were identified.

• Brand Name: TRUESPAN 12 DEGREE PEEK
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9663119
• MDR Text Key: 204066179
• Report Number: 1221934-2020-00452
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: L705467
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Patient Sequence Number: 1