MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 24 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228152

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

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.Udi: (b)(4).The expiration date is unknown.

Event Description

It was reported by the sales rep via phone that during an acl procedure the truespan meniscal repair system peek 24 degree misfired.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The device will be returned for evaluation.

Manufacturer Narrative

Product complaint # (b)(4).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: investigation summary: the complaint device was received and inspected.The red trigger is very loose, and the device could not be tested for its functionality.The trigger handle is shaking as if it was missing an inner component that holds it in place or has a broken inner component.It seems like the handle's internal component was broken which caused trigger to be loose.Further observation revealed that the needle was heavily bent upward.The bent needle and broken handle could contributed to the reported condition.The complaint can be confirmed.No definitive root cause could be determined; however, it is likely that the device experienced excessive force.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.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.Udi: (b)(4).The expiration date is unknown.

• Brand Name: TRUESPAN 24 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: 9707529
• MDR Text Key: 201021703
• Report Number: 1221934-2020-00561
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026029
• UDI-Public: 10886705026029
• 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,other
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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 Model Number: 228152
• Device Catalogue Number: 228152
• Device Lot Number: 5L95614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 04/03/2020
• Patient Sequence Number: 1