MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.7X5MM, MIDFACE, (5/PACKAGE); IMPLANT

Catalog Number 50-17905

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2018

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.Please note the actual device quantity is 5.

Event Description

It was reported by a company representative that during a procedure to fixate a zmc fracture the head of a screw broke off from the screw body while the surgeon was self-drilling the screw into the bone without using a drill beforehand.No medical intervention and no adverse consequences were reported with this event.The procedure was completed successfully without a delay.

Manufacturer Narrative

It is recommended that shorter screws (=4 mm) be used in bone that is known to be dense (e.G.Cranial bone) in order to avoid excessive axial forces and torque.Should the screws be difficult to start in bone, a pilot hole should be drilled to facilitate insertion, especially by use of screws with a length of more than 4 mm.The reported event could be confirmed due to the visual inspection.The reported event screw shows a fracture and a crack.The (measurable) dimensions are in accordance with the specifications of the returned screw.Because a fragment of the reported screw is broken off and was not returned, the chemical composition was tested and conforms to the specification tial6v4 (ti grade 5).The investigation of the reported broken screw shows that due to too high torsional forces originated during the screw in, and resulted in high bending forces, one wing of the cross-pin is broken off.The investigation with sem shows on the fracture surface the typical honeycomb structure of a ductile forced fracture resulting from too high bending forces.Furthermore, the investigation results for the other concomitant returned screws (#2-5) show damages on the cross pin in screw in and unscrew direction.Additionally, the bending overload is displayed in the damages of the pin holes.One screw also shows damage that points to very high bending forces, which occurred during insertion of the screw into the bone.Some screws also show friction marks on the thread as a result from collision and friction with a very hard bone.As stated in the ifu it is recommended that shorter screws (=4 mm) be used in bone that is known to be dense (e.G.Cranial bone) in order to avoid excessive axial forces and torque.Should the screws be difficult to start in bone, a pilot hole should be drilled to facilitate insertion, especially by use of screws with a length of more than 4 mm.No lot numbers were provided, thus a review of the specific manufacturing batch records and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) cannot be performed.Therefore, it is also not possible to determine the quantity released for distribution within the affected lot.To obtain more details about the complained event, the sales rep was contacted.It was reported that blade # 62-12170 has been used for this case.This blade is intended to be used with screws of the upper-face and mid-face fixation modules with a diameter of 1.2mm and 1.7mm.Therefore they are intended to be used in combination with each other.Based on the investigation and the corresponding statistical evaluation there is no indication for an incorrectly working product or any systematic design, material, or manufacturing related issue.Therefore, no further 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 procedure to fixate a zmc fracture the head of a screw broke off from the screw body while the surgeon was self-drilling the screw into the bone without using a drill beforehand.No medical intervention and no adverse consequences were reported with this event.The procedure was completed successfully without a delay.

• Brand Name: BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.7X5MM, MIDFACE, (5/PACKAGE)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7288366
• MDR Text Key: 100906780
• Report Number: 0008010177-2018-00023
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

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: 50-17905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Manufacturer Received: 02/03/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 02/03/2018
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1