MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREWS, SELF DRILLING, 2.0X8MM, 5/P; IMPLANT

Catalog Number 50-20598

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported by the company representative that during a medical procedure, the surgeon implanted arch bars and began putting wires on the bars.When the surgeon was tightening the wires, the head of hmmf screw fractured off.The case proceeded with no further complications and was completed successfully.A "hall" drill was used to remove the remaining screw shaft of the broken screw.The surgeon was using stryker products correctly, per ifu standards.

Manufacturer Narrative

The product was returned for investigation and the reported event could be confirmed.The investigation shows that the screw broke as a result of too high torsional forces in forced rupture mode during the insertion.The broken shaft/tip of the screw was very strongly damaged during the removal from the patient.The fracture surface shows the typical flow structures of ductile torsional breakages.The root cause of the failure could have been a too hard bone.The screw could have been weakened during the insertion, because of too high torsional forces on the screw.Finally when the wiring was applied the shear force increased and the screw head finally broke off.Furthermore in the related risk management file these possible root causes were stated: - incorrectly selected/ assembled implant/ instrument - insufficient/too high bone quality - wrong/ missing information - implant/instrument mix-up - improper implant placement - too much/ wrong forces between blade, screw and bone (e.G.Screw head deformation, screw breakage) - power tool usage for screw insertion (except qdm) - too much/ wrong compression/ torsional/ axial forces - bone quality resulting in high torque - powered screw insertion with right angled screwdriver.Based on the evaluation no indications for any design, material or manufacturing related problems were found in this investigation.

Event Description

It was reported by the company representative that during a medical procedure, the surgeon implanted arch bars and began putting wires on the bars.When the surgeon was tightening the wires, the head of hmmf screw fractured off.The case proceeded with no further complications and was completed successfully.A "hall" drill was used to remove the remaining screw shaft of the broken screw.The surgeon was using styrker products correctly, per ifu standards.

• Brand Name: LOCKING SCREWS, SELF DRILLING, 2.0X8MM, 5/P
• 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: 5735980
• MDR Text Key: 48724916
• Report Number: 0008010177-2016-00132
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-20598
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2016
• 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