MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.7X3MM, MIDFACE, (5/PACKAGE); IMPLANT

Catalog Number 50-17003

Device Problems Connection Problem (2900); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

The complained screws were returned for investigation.Nevertheless, a confirmation of the reported event is not applicable since not enough information were provided.The visual inspections of the screws showed significant marks of usage on the screw heads as well on the threads.However, the measured dimensions of the returned screws conform to specification except for one minor deviation most likely due to a deformation of the screw head.With respect to the complained plates it could be determined that the complained screws were only appropriate for three of the four returned plates since the diameters of the screws and the plate holes have to be corresponding.The complained 1.7 mm screws were not intended to be used with the complained plate # 55-06231 that is characterized by 1.2 mm hole diameter.This discrepancy could have led to an unsufficient fixation of the screws and plates.Regarding the all other matching interfaces between the 1.7 mm screws and the returned plates with appropriate 1.7 mm screw holes a possible root cause of the fixation issue can not be further specified.In general, the usage of stryker implants along with products of other manufacturer as reported in the event is not recommended according to the applicable instructions for use.Finally, the exact root cause of the reported event could not be determined since requested information regarding used instruments and present patient conditions had not been provided.According to the related risk management file, the most likely root causes could have been: - wrong pilot hole - screw interface due to wrong hole diameter/ tapped hole, - incorrectly selected implants, - incorrectly selected/ assembled implant/ instrument, - insufficient/too high bone quality, - wrong/ missing information, - implant/instrument mix-up, - wrong/ missing functionality check, - improper implant placement (e.G.Arch bar, screw.), - too much/ wrong forces between blade, screw and bone (e.G.Screw head deformation, screw breakage), - usage of self-tapping screw without pilot hole/ bone screw without tapping, - power tool usage for screw insertion (except qdm), - deformation of hole during bending, - plate becomes loose during fixation.Based on statistical evaluation there are no indications for any systematic design, material or manufacturing related issue.

Event Description

It was reported that 1.7 mm screws could not be fixated to the patient, as the screws would back out of the bone, during the procedure.

Manufacturer Narrative

The complained screws were returned for investigation.Nevertheless, a confirmation of the reported event is not applicable since not enough information were provided.The visual inspections of the screws showed significant marks of usage on the screw heads as well on the threads.However, the measured dimensions of the returned screws conform to specification except of one minor deviation most likely due to a deformation of the screw head.With respect to the complained plates it could be determined that the complained screws were only appropriate for three of the four returned plates since the diameters of the screws and the plate holes have to be corresponding.The complained 1.7 mm screws were not intended to be used with the complained plate # (b)(4) that is characterized by 1.2 mm hole diameter.This discrepancy could have led to an unsufficient fixation of the screws and plates.In general, the usage of stryker implants along with products of other manufacturer as reported in the event is not recommended according to the applicable instructions for use.Due to the fact that the complained stryker implants were used in combination with a non-stryker implant the usage of the complained stryker products is considered as an off-label use.Based on statistical evaluation there are no indications for any systematic design, material or manufacturing related issue.Therefore no preventive and/or corrective actions are deemed necessary at this time.The complaint is added to the complaint trend.

Event Description

It was reported that 1.7mm screws could not be fixated to the patient, as the screws would back out of the bone, during the procedure.

• Brand Name: BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.7X3MM, MIDFACE, (5/PACKAGE)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6732329
• MDR Text Key: 80696743
• Report Number: 0008010177-2017-00173
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-17003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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