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

Model Number 228152

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Positioning Failure (1158); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2020

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).The expiration date is unknown.

Event Description

It was reported by the sales rep via phone that during a meniscal repair procedure the second implant of the truespan meniscal repair system peek 24 degree did not deploy.Another device was used to complete the procedure.No patient consequences or surgical delay.The device was discarded by the staff.

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: investigation summary the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (3l68985), and no non-conformances related to the reported complaint condition 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 number (3l68985), and no non-conformances related to the reported complaint condition were identified.

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: correction: b5: it was inadvertently missed on the initial report that the needle angle was 24.It was reported that the location and type of repair was medial.It was reported that the surgeon fully depressed the trigger on the first implant then it deployed while the second implant would not fire.It was reported that the surgeon had to used both hands to try and deploy.It was reported that the trigger was stuck but it finally clicked with a breaking or snapping sound.It was reported that the trigger was thus broken.It was reported that the tip of the needle was still in scope view.It was reported that the surgeon penetrated the meniscus all the way to the depth stop.It was reported that the procedure/repair was completed by another 24 degree truespan.It was reported that the surgeon did not need to use a probe.It was reported that the failure occurred with the second implant.It was reported that the detached implants were removed by a grasper.H6: device codes: upon complaint review, it was determined that the device codes on the initial report were incorrect.The device codes have been updated accordingly to reflect the correct malfunctions.Additional information d4: the expiration date has been updated to reflect the correct information.Therefore, udi: (b)(4).

• 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: 10067597
• MDR Text Key: 202081935
• Report Number: 1221934-2020-01403
• 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,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 228152
• Device Catalogue Number: 228152
• Device Lot Number: 3L68985
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Patient Sequence Number: 1