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

Catalog Number 228161

Device Problem Mechanical Jam (2983)

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.(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 handle on their truespan plga 12 degree jammed after firing the first implant.When going to fire the second implant the handle broke, the second implant deployed but never implanted in the patient.The surgeon removed the first implant.The procedure was completed with another like device with no patient harm but there was a two minute surgical delay to the case.The device was discarded by the customer.

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.Investigation summary : the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.One possible root cause of the reported problem could be the excess force applied on the handle.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.A manufacturing record evaluation was performed for the finished device lot number [4l51638], 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 number [4l51638], and no non-conformances were identified.

• Brand Name: TRUESPAN 12 DEGREE PLGA
• 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: 9433195
• MDR Text Key: 208181356
• Report Number: 1221934-2019-59882
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026043
• UDI-Public: 10886705026043
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228161
• Device Lot Number: 4L51638
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 12/24/2019
• Patient Sequence Number: 1