MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INTRAFX ADVBR SCW9X30 W/LGSHTH; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 254808

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 email that during an acl revision procedure their intrafix advance br large 9x30mm, the surgeon had prepped the tibial tunnel and soft tissue allograft appropriately.The allograft was fixated on the femoral side, knee cycled, then the tibial side was put on the tie tensioner and ready to receive the intrafix advance implants.They had a 10mm graft so were using the appropriate large trial.It wasn¿t going down very well, so they used the small trial to create a better path.Once they got the small trial down smoothly, they then went back to the large trial and got it seated.The surgeon opted to downsize the screw to the 9x30mm since things just seemed to be a bit tight.The sheath was implanted using the large 30mm sheath inserter.As they started to insert the screw into the sheath, the sheath was backing out and just crumbling into pieces.After the screw was about 1/3 to ½ way in, the screw and sheath were just trying to turn together as one unit.It was clear they were not going to get the screw seated and the sheath was shredded.The surgeon backed the screw out, used a hemostat to remove the pieces of the sheath, and then opted to use a richard¿s staple to fixate the graft distally.There was no patient harm.Additional information received from the affiliate reported a 5 minute surgical delay occurred while trying to remove the broken pieces of shealth and the case was completed by using 2 richards staples to fixate the graft on the tibial side.The affiliate reported an alternative product was available but the surgeon decided to use the staples because she thought the graft maybe was twisted in the tunnel making a clear pathway for the implants difficult, and since the sheath was in so many pieces she wasn¿t positive all of it was out and didn¿t want to risk pushing any pieces into the joint space.No patient or user consequences were noted and surgical intervention is not planned.It was also reported that the broken screw was removed and it was unknown if all pieces were removed.

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.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.H4: device history.No nonconformances were identified for this part-lot number combination per query executed.H11 corrected data.E1 facility information; facility contact.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.

• Brand Name: INTRAFX ADVBR SCW9X30 W/LGSHTH
• 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: 8903428
• MDR Text Key: 155960873
• Report Number: 1221934-2019-58031
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705026753
• UDI-Public: 10886705026753
• Combination Product (y/n): N
• PMA/PMN Number: K160804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 254808
• Device Lot Number: L296316
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 09/09/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention