MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE Ø3.0MM / L18MM; PLATE, FIXATION, BONE

Catalog Number PLSL3018S

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The customer reported that the lisfranc plate has broken after implantation.The device was implanted on (b)(6) 2016.The patient was non weight bearing for 6 weeks after being implanted.In late (b)(6) 2016 patient complained of pain over top of left foot keeping her awake at night.Steroid injection given to help relieve pain on that visit.On (b)(6) 2017 patient said that the pain was no better and steroid injection did not help.X rays requested and 1 broken screw was visible and noted.Patient will have the screw and plate removed on (b)(6) and during procedure 2nd broken screw was discovered.All screws and plates removed in procedure.(b)(6) consultant podiatric surgeon stated that the compression hole in the plate was not used in the original procedure.

Manufacturer Narrative

The reported event that locking screw anchorage ¿3.0mm / l18mm was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be device unrelated.The failure was caused by fatigue.The microscopic inspection revealed that the fracture surface had suffered severe secondary damage.Evidence of microscopic vibration fracture characteristics was found on the fracture surface.Even if bone fusion occurred and was confirmed before patient was originally discharged, it has been reported that patient was only 2 weeks non-weight bearing and 4-6 weeks in air cast boot.This early mobilization had most likely fragilized the screw structure and initiated the fatigue solicitations.Please note that the instruction for use v15096 anchorage sterile ((b)(4))) reads: ''precautions for use the product does not allow the immediate resumption of activity by the patient and is not designed to support an immediate load.Immobilization is necessary during the osteosynthesis.It is necessary to inform the patient of the precautions to be taken to ensure the success of the implantation.[original statement].The anchorage plate system is an internal fixation system which shall fix bone segments in a correct position until sufficient bone consolidation is achieved.The anchorage plating system is not intended to transmit full forces and bending moments of daily routine.Loading and weightbearing have to be individually reduced.Influence factors for the required load reduction are: the type and the localization of fixation, the bone quality (e.G.Strong bone in younger patients vs.Osteoporotic bone), correct fixation technique (e.G.Correct dimension of the plate, correct positioning of the plate, sufficient length of the plate and the screws, p g p, g p, sufficient bending of the plate, correct screw placement with sufficient insertion torque).In addition, a steroid injection was performed next to the implanted screw, when the instruction for use ((b)(4) anchorage sterile ((b)(4))) reads: ''never perform intramuscular injection next to the implant.[original statement].Therefore this case is closed as user/patient related.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

The customer reported that the lisfranc plate has broken after implantation.The device was implanted on (b)(6) 2016.The patient was non weight bearing for 6 weeks after being implanted.In late (b)(6) 2016 patient complained of pain over top of left foot keeping her awake at night.Steroid injection given to help relieve pain on that visit.(b)(6) 2017 patient said that the pain was no better and steroid injection did not help.X rays requested and 1 broken screw was visible and noted.Patient will have the screw and plate removed on (b)(6) and during procedure 2nd broken screw was discovered.All screws and plates removed in procedure.(b)(6) -consultant podiatric surgeon stated that the compression hole in the plate was not used in the original procedure.

• Brand Name: LOCKING SCREW ANCHORAGE Ø3.0MM / L18MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6818902
• MDR Text Key: 83605088
• Report Number: 0008031020-2017-00494
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K083447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

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: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: PLSL3018S
• Device Lot Number: V01683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention