MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.7X4MM, MIDFACE, (5/PACKAGE); IMPLANT

Catalog Number 92-17994

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/21/2016

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 prosthetic ear procedure the self-drilling screw broke off at the head of the screw while being drilled into the cranium.The head part of the screw that broke off was recovered, and the remaining part of the screw was left in the patient.It was reported that the procedure was completed successfully without a delay.No medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The product was not returned for investigation, and not enough further information was provided.Therefore, the event cannot be confirmed, and a thorough examination is not possible.According to the related design risk analysis, these are possible root causes: - incorrectly selected implants - insufficient/too high bone quality - wrong/ missing information - reuse of single-use devices - 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) - wrong/ missing information - 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 preventive and/or corrective 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 prosthetic ear procedure the self-drilling screw broke off at the head of the screw while being drilled into the cranium.The head part of the screw that broke off was recovered, and the remaining part of the screw was left in the patient.It was reported that the procedure was completed successfully without a delay.No medical intervention and no adverse consequences were reported with this event.

• Brand Name: BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.7X4MM, 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: gregory gohl ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5832974
• MDR Text Key: 51759772
• Report Number: 0008010177-2016-00159
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022185
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 92-17994
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 07/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• 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