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

Model Number 228151

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.(b)(4).

Event Description

It was reported that this was a meniscal suturing procedure in the right knee performed on (b)(6) 2020.After the 1st implant was deployed with the truespan peek (228151) without an issue, it was quite tight to deploy the 2nd one.Finally the 2nd implant came out with bursting noise but was deployed to a non-targeted location.It was postoperatively found that the extruding rod did not react to triggering.There was no surgical delay and no harm to the patient.The device was the first use when the issue occurred.Additionally information provided by the affiliate reported the case was completed but additional information regarding the event could not be provided.The device will be returning for evaluation.

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.H10 additional narrative: d10, 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.

Manufacturer Narrative

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: investigation summary
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> the complaint device was received and evaluated.Visual inspection, there was no damage noticed on the needle.Upon functional testing, the trigger was found to be jammed at first attempt.Upon second attempt, the trigger handle is shaking as if an inner component that holds it in place or has a broken inner component.It seems like the broken internal component stuck in between or causing jammed condition.No definitive root cause could be determined; however, it is likely that the device experienced excessive force.A manufacturing record evaluation was reviewed, no non-conformances were identified for the reported part 228151- lot l80270 number combination.At this point, 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 review
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> a manufacturing record evaluation was reviewed, no non-conformances were identified for the reported part 228151- lot l80270 number combination.

• 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: 9949622
• MDR Text Key: 207964074
• Report Number: 1221934-2020-01132
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 4L80270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Date Manufacturer Received: 05/08/2020
• Patient Sequence Number: 1