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 Device Embedded In Tissue or Plaque (3165)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.The product was discarded by the facility at their location.

Event Description

It was reported by a company representative that during a mandible reconstruction procedure the screw head broke off from the screw body right under the locking threads during torque/insertion.The head part of the screw that broke off was recovered and discarded by the operating room staff, and the remaining part of the screw body was left in the patient bone.The procedure was completed successfully without a delay.There was no medical intervention reported.

Manufacturer Narrative

The reported event could not be confirmed since the product was not returned.Due to the missing product the exact root cause cannot be determined.According to the related risk management file, these are possible root causes: insufficient/too high bone quality.Wrong/ missing information.Wrong/ missing functionality check.Reuse of single-use devices.Improper implant placement (e.G.Arch bar, screw.).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.Wrong rotational speed, unintended loads.Bone quality resulting in high torque.Improper blade disengaging.Collision with other implant or instrument.Powered screw insertion with right angled screwdriver.Based on statistical evaluation there are no indications for any systematic design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.

Event Description

It was reported by a company representative that during a mandible reconstruction procedure the screw head broke off from the screw body right under the locking threads during torque/insertion.The head part of the screw that broke off was recovered and discarded by the or staff, and the remaining part of the screw body was left in the patient bone.The procedure was completed successfully without a delay.There was no medical intervention reported.

• 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: gregory gohl ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6366471
• MDR Text Key: 69018659
• Report Number: 0008010177-2017-00038
• Device Sequence Number: 1
• Product Code: JEY
• 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
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

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: Health Professional
• Device Catalogue Number: 50-20598
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 02/28/2017
• Supplement Dates Manufacturer Received: 02/17/2017
• Supplement Dates FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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