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 Not Applicable (3189)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).The expiration date is unknown.

Event Description

It was reported by affiliate via complaint submission tool that during a meniscal repair truespan 12 degree peek and the truespan 24 degree peek misfired.The procedure was completed using devices from competitor.No patient consequence, however there was a 10 minute surgical delay reported.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.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.Upon inspection it was noticed that the both implants were received in released condition but still attached to the suture.It was observed that the needle was bent upward.The trigger of the device was functioning as intended upon squeezing, the misfired condition cannot be replicated based on received condition of the device.But, the provided image by the customer shows that the one of the implant is in released condition (sill attached to the suture) and second implant is not visible.It is possible that bent condition of needle may caused difficulty in firing or misfiring but could not be replicated at cq since the implants were received in released/deployed condition.When the needle became bent, it may be possible that the sleeve blocked the deployment of the second implant upon being fired therefore causing the device to misfire.Hence, the complaint can be confirmed.It is possible that the surgeon was using excessive force when using the device which may bent the needle.However, given the information provided we cannot discern any definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances related to the reported complaint condition were identified.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: a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances related to the reported complaint condition were identified.

• 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: 9466579
• MDR Text Key: 204779539
• Report Number: 1221934-2019-59960
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2019

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: 2L82034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 02/13/2020; 02/21/2020
• Supplement Dates FDA Received: 02/14/2020; 02/21/2020
• Patient Sequence Number: 1