MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228151

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem Not Applicable (3189)

Event Date 11/07/2019

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 the sales rep via phone that during a meniscal repair procedure the first implant of the customer's truespan peek 12 degree deployed fine but when the surgeon went to deploy the second implant the spring within the handle of the device broke and the second implant was unable to deploy.The first implant was removed with no issues.The procedure was completed with another like device with no patient harm but there was a three minute surgical delay to the case.The sales rep was not present for the case therefore could not provide any further information.The device will be returning 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.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 evaluated.Visual inspection reveals both implants are missing from the silicone tube.Hence, the reported failure of the second implant unable to deploy cannot be confirmed.However, when the red trigger was activated it was found to be defective/loose and did not function as intended.Therefore, confirming the reported failure of the spring being broken in the handle.This failure can be attributed to user technique.It is possible that during the procedure, the surgeon could have applied excessive force to the device when inserting it against a hard surface causing the second implant not to deploy and therefore impacting the spring in the handle.Furthermore, a manufacturing record evaluation was performed for the finished device [2l16307] number, 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 [2l16307] number, 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: 9373417
• MDR Text Key: 207563656
• Report Number: 1221934-2019-59779
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 228151
• Device Lot Number: 2L16307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Date Manufacturer Received: 01/02/2020
• Patient Sequence Number: 1