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

Catalog Number 50-17004

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported that during an open reduction procedure of multiple facial fractures, the head of a screw snapped off while the surgeon was inserting the screw to secure the plate.An attempt was made to retrieve the implanted shaft, but was unsuccessful.

Manufacturer Narrative

The reported event could not be confirmed, since the complained device was not returned for investigation.Due to the missing product the exact root cause cannot be determined, but according to the risk management file, these are possible root causes: wrong pilot hole - screw interface due to wrong hole diameter/ tapped hole; incorrectly selected assembled implant/ instrument; insufficient/too high bone quality; wrong/ missing information; reuse of single-use devices; 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); too much/ wrong compression/ torsional/ axial forces; wrong rotational speed, unintended loads; improper blade disengaging; collision with other implant or instrument; predrilled hole not deep enough (e.G.Wrong choice of instrument/implant, system mixup, poorly assembled/used instrument).Based on the statistical evaluation there is no indication for any systematic design, material or manufacturing related issue.The complaint is added to the complaint trend.

Event Description

It was reported that during an open reduction procedure of multiple facial fractures, the head of a screw snapped off while the surgeon was inserting the screw to secure the plate.An attempt was made to retrieve the implanted shaft, but was unsuccessful.

• Brand Name: BONE SCREWS, CROSS-PIN, SELF-TAPPING, 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: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5842892
• MDR Text Key: 51025222
• Report Number: 0008010177-2016-00179
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

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: 50-17004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: No
• 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