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 Not Applicable (3189)

Event Date 01/04/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).

Event Description

It was reported by the affiliate via complaint submission tool that during a knee arthroscopy with meniscal repair the second implant of the truespan 12 degree peek got stuck in the shaft of the gun therefore it didn¿t do due to the deployment.The procedure was completed with a new device.No patient consequence was reported, but there was a surgical delay from 10 to 15 minutes.No additional information was provided.

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

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 was received and evaluated.Visual observation reveals that device was received intact.No suture or implant is received with the device.Functional test was performed by squeezing the trigger and the deployment rod was passing through the needle as intended.It means that no implant or suture was stuck inside the shaft of the device.Thus, the reported complaint cannot be confirmed.No definitive root cause could be determined for the reported failure.An mre was reviewed, no non-conformances were identified for the reported part 228151- lot 5l44860 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 lot
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> a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), 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: 9582574
• MDR Text Key: 206736740
• Report Number: 1221934-2020-00150
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2020

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 Expiration Date: 06/30/2022
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 5L44860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Manufacturer Received: 01/04/2020
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 02/13/2020; 03/02/2020
• Supplement Dates FDA Received: 02/14/2020; 03/03/2020
• Patient Sequence Number: 1