MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 0 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228150

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2020

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.Udi: (b)(4).

Event Description

It was reported by affiliate via complaint submission tool that during arthroscopy the truespan 0 degree peek had the securing ends came out at the same time in the shot.The procedure was completed with another truespan device.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.

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.D4: the unique identifier( udi) has been updated to reflect the correct information.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

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 device was received and inspected.Upon visual inspection, it was noticed that the one of the implant was in deployed/released condition (still attached to the suture/gun) and the second implant was within the channel.Visual observation revealed no anomalies.Functional testing was performed, second implant was able to be released upon squeezing trigger.The complaint cannot be confirmed as there is no issue find out with deployment of implants.A manufacturing record evaluation was performed for the finished device [3l05496] number, and no non-conformances were identified.We cannot determine what caused the user to experience reported problem.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
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> a manufacturing record evaluation was performed for the finished device [3l05496] number, and no non-conformances were identified.

• Brand Name: TRUESPAN 0 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: 9831757
• MDR Text Key: 205303460
• Report Number: 1221934-2020-00851
• Device Sequence Number: 1
• Product Code: MBI
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/29/2020

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: 01/31/2022
• Device Catalogue Number: 228150
• Device Lot Number: 3L05496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Initial Date Manufacturer Received: 02/29/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 04/02/2020; 04/28/2020
• Supplement Dates FDA Received: 04/03/2020; 04/29/2020
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 27