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 Problems Foreign Body In Patient (2687); Not Applicable (3189)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the affiliate in (b)(6) that during meniscal repair, it was observed that the first implant fired, and the second implant did not fire.It was reported that after trying two to three times, the device had to be changed and the surgeon used other truespan 12 degree peek device.The second implant worked okay.It was reported that the implant was not used at an incorrect angle.It was reported that no patient harm was done.It was reported that the delay in this entire procedure was five to ten minutes.It was reported that the implant could not be retrieved as one of of the implant was implanted in the body.There was a delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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.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.Additional information: event description concomitant medical products - device returned.Evaluation codes - patient codes.Udi: (b)(4).

Event Description

Additional information received from the affiliate reporting the implant remained in the capsule and there were no patient consequences.

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.Additional narrative: investigation summary: the complaint device was received and evaluated.A visual inspection was performed to determine if the device had any gross visual defects that may contribute to the reported failure.The shaft is deformed and damaged at the distal tip.The needle and implants were not returned with the device.The reported failure states that the second implant did not fire.However, no implants were returned on the device, therefore the reported failure cannot be confirmed.The pusher rod was evaluated, via functional testing the trigger was pulled.A click was heard, indicating the pusher rod by itself was functional.We cannot determine a definitive root cause for the physical damage on the device, however one possible root cause can be attributed to user mishandling of the device.Furthermore, a manufacturing record evaluation was performed for the finished device lot number (b)(6), 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: 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: 9355158
• MDR Text Key: 208322611
• Report Number: 1221934-2019-59664
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 3L18677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 11/21/2019; 01/28/2020
• Supplement Dates FDA Received: 12/20/2019; 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1