MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, DIAM.2.0X10MM, (5/PACKAGE); IMPLANT

Catalog Number 50-20410

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

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

Event Date 12/28/2017

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 a mandible surgery, the head of the screw fractured off.There was no medical intervention nor adverse consequences reported.

Manufacturer Narrative

The reported event could be confirmed.In the related ti 5023/18 it was stated: one bone screw, cross-pin, 2.0xxxmm broken during surgery, was returned in order to determine the root cause of the failure.The returned screw was examined regarding its dimensions, chemical composition (edx analysis) as well as by light and scanning electron microscopy.The (measurable) dimensions are in accordance with the specification.The chemical composition conforms to the specification - tial6v4 (ti grade 5).The investigation shows that the screw broke as a result of too high torsional forces in forced rup-ture mode during the insertion.The fracture surface shows the typical flow structures of a ductile torsional breakage.The root cause of the failure could have been a too low deepness of the pilot hole.Indications for material or manufacturing related problems were not found in this investigation.Further information was requested several times in order to gain more insight in the reported event.The lot number of the screw could not be provided.However, the sales representative has mentioned that the used blade was a 62-20130.The blade is intended to be used for 2.0/2.3 mm screws.The affected screw has a diameter of 2.0 mm.Therefore the reported blade is appropriate to be used with the screw.Also in the reported event, it has been mentioned that a plate (55-10503) and a drill (60-16526) were used during surgery.These devices including the used blade and the affected screw are part of the mandible fixation module.Implants and instruments are produced and designed to be compatible for use in their respective system.

Event Description

It was reported that during a mandible surgery, the head of the screw fractured off.There was no medical intervention nor adverse consequences reported.

• Brand Name: BONE SCREWS, CROSS-PIN, DIAM.2.0X10MM, (5/PACKAGE)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7211814
• MDR Text Key: 98408858
• Report Number: 0008010177-2018-00004
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-20410
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Date Manufacturer Received: 12/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1