MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/46MM; CERCLAGE, FIXATION

Catalog Number 42.231.246

Device Problems Device-Device Incompatibility (2919); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that an unknown optilink screw slipped through a va lcp condyle plate.The original surgery was performed on (b)(6) 2020.The plate dislocation was noticed post-surgery on (b)(6) 2020.Due to cardiological problems, the patient underwent revision surgery on (b)(6) 2020.The procedure was successfully completed.The patient was reported as stable after the procedure.Concomitant devices reported: va-lcp condylar plate 4.5/5.0 r 10ho l23 (part # 04.124.410s, lot # 2l69584, quantity 1); screw (part # unknown, lot # unknown, quantity 1); va lockscr ø5 optilink techn self-tap l3 (part # 42.231.238, lot # 5l93875, quantity 1); va lockscr ø5 optilink techn self-tap l4 (part # 42.231.242, lot # 5l74325, quantity 1); va lockscr ø5 optilink techn self-tap l5 (part # 42.231.250, lot # 3l02927, quantity 1).This report is for one (1) 5.0mm val screw/optilink(tm) slf-tpng/strdrv/46mm.This is report 5 of 6 for (b)(4).

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, h4, h6: part: 42.231.246, lot: l223799, manufacturing site: mezzovico, release to warehouse date: march 20, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no relevant non-conformances were identified.The x-ray image from october 02, and the damage found on the plate and screws, confirm the statement of the proximal screws (hole #1, #3, #4 and #5) being buttoned through the plate.The flattened grooves and thread flanks of the va-lcp locking holes and on the screw heads indicate this.The fine grooves running along the circumference of the hole, as well as the bumps and steps, indicate that screw loosening and slip through occurred continuously in a stepwise manner due to cyclic loading.The wear marks on the upper part of the va-lcp locking holes #1 and #5 indicate that screws had loosened and moved back and forth in the hole.It cannot be confirmed if the screws in hole #4 and hole #5 were completely buttoned through at the time of the x-ray image on (b)(6) 2020.The x-ray image shows that the screw in hole #4 is only partially protruding from bottom of the plate and the screw in hole #5 is still completely covered by the hole.However, the scuff marks on the bottom of hole #5 and hole #6 indicate that the screw of hole #5 was slipped through at the time of implant removal.The screw head of the screw from hole #5, anchored in the bone, has most probably rubbed at these points.On the x-ray image of (b)(6) 2020, it can be seen that the proximal part of the femur (shaft) has been repositioned slightly laterally in relation to the femoral condyle.In addition, there is a distance between plate and bone.It is likely that the lateral offset and this distance resulted in an increased cyclic force magnitude on the proximal screws, which ultimately led to the stepwise slip-through.Based on the findings described above, it can be concluded that the failure was not caused by the product design.The visual inspection showed no design or functional related issues.Thus, the complaint cannot be confirmed.No action is required, as no design issues were detected.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/46MM
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11004542
• MDR Text Key: 222636481
• Report Number: 8030965-2020-09685
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07612334100146
• UDI-Public: (01)07612334100146
• Combination Product (y/n): N
• PMA/PMN Number: K162124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42.231.246
• Device Lot Number: L223799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 01/19/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA; VA LOCKSCR Ø5 OPTILINK TECHN SELF-TAP L3; VA LOCKSCR Ø5 OPTILINK TECHN SELF-TAP L4; VA LOCKSCR Ø5 OPTILINK TECHN SELF-TAP L5; VA-LCP CONDYLAR PLATE 4.5/5.0 R 10HO L23
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR