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

Catalog Number 50-20598

Device Problem Break (1069)

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

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device unable to be returned.

Event Description

It was reported that the surgeon was doing a mandible fx and was inserting the hybrid mmf screw and the screw broke.A handheld screwdriver was used.The procedure was completed successfully after using another screw.No significant delay and no adverse consequence was reported.

Event Description

It was reported that the surgeon was doing a mandible fx and was inserting the hybrid mmf screw and the screw broke.A handheld screwdriver was used.The procedure was completed successfully after using another screw.No significant delay and no adverse consequence was reported.

Manufacturer Narrative

The device was not returned for investigation.Additional information regarding the event has been requested.The sales representative has provided the following details; the surgeon had used the 2.0/2.3 mm universal screwdriver blade (62-20130), along with the universal screwdriver handle, ratchet (62-20290) during surgery.The devices including the broken screw are part of the hybrid mmf module.Implants and instruments are produced and designed to be used together.The sales representative has mentioned that, the breakage occurred when the screw was inserted 6-7mm in the bone and that the thread of the screw was left in patient.The following are examples of possible root causes according to the related risk management file: wrong pilot hole - screw interface due to wrong hole diameter/ tapped hole.Improper implant placement (e.G.Arch bar, screw.).Too much/ wrong forces between blade, screw and bone (e.G.Screw head deformation, screw breakage).Too much/ wrong compression/ torsional/ axial forces.This is confirmed by previous investigations ((b)(4)) where it was determined that intraoperative screw breakages were the result of too high torsional forces in forced rupture mode during insertion.Product was not returned to evaluate.

• 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
• MDR Report Key: 7842261
• MDR Text Key: 119504513
• Report Number: 0008010177-2018-00084
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 34546540732058
• UDI-Public: 34546540732058
• Combination Product (y/n): N
• PMA/PMN Number: K122313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

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: 50-20598
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1