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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, DIAM.2.3X10MM, (5/PACKAGE); IMPLANT
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STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, DIAM.2.3X10MM, (5/PACKAGE); IMPLANT Back to Search Results
Catalog Number 50-23410
Device Problems Detachment Of Device Component (1104); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2018
Event Type  malfunction  
Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
 
Event Description
It was reported by the company representative that during an orthognathic/double jaw case, a screw fractured off at the head.The product was recovered from the patient, and no adverse consequences nor medical intervention was reported.
 
Manufacturer Narrative
The reported event could be confirmed.In the related (b)(4) it was stated: ¿(¿) one bone screw, cross-pin, diam.2.0x10mm 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 because of too high torsional and tensile forces (whereas the torsional forces prevailed) during the insertion.The friction traces on the bottom side of the head show that this screws already contacted the plate and were further tightened.The broken tip of the screw (thread fragment) was strongly damaged and the fracture surface completely destroyed by medical instruments during the removal from the patient.The intact fracture surfaces show the typical flow structure of a ductile torsional breakage and additionally the honeycomb structure of a ductile forced rupture caused by high tractive forces.The root cause of the failure was the fact that after the screw contacted the plate it was forcibly further turned.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 sales representative has provided the catalog number of the used blade and drill.The blade is designed and is intended to be used for 2.0 mm, 2.3 mm screws, therefore this blade is appropriate to be used with the affected screw.The drill is intended to be used for screw lengths between 10 to 20 mm as illustrated in the leibinger brochure (fig.1).Thus, the drill bit is suitable for use with the affected screw.The drill bit suggested by the company representative is intended only for screws with lengths of up to 7 mm.Regardless, during investigation, it was found out that the root cause was due to the screw being overtightened.
 
Event Description
It was reported by the company representative that during an orthognathic/double jaw case, a screw fractured off at the head.The product was recovered from the patient, and no adverse consequences nor medical intervention was reported.
 
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Brand Name
BONE SCREWS, CROSS-PIN, DIAM.2.3X10MM, (5/PACKAGE)
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
MDR Report Key7288363
MDR Text Key101009164
Report Number0008010177-2018-00021
Device Sequence Number1
Product Code JEY
Combination Product (y/n)N
PMA/PMN Number
K022185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number50-23410
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2018
Date Manufacturer Received01/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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