MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREWS, CROSS-PIN, DIAM.2.0X8MM, (5/PACKAGE); IMPLANT

Catalog Number 50-20508

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

Patient Problem Foreign Body In Patient (2687)

Event Date 08/12/2016

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 a company representative that during a mandible angle fracture procedure, the screw head broke off from the screw body during torque/insertion.The head part of the screw that broke off was recovered, and the remaining part of the screw body was left in the patient bone.There was no medical intervention reported, and the procedure was completed without a delay.

Manufacturer Narrative

The reported event could be confirmed.The investigation results shows that the screw broke as a result of too high torsional forces in forced rupture 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 small diameter or a too low deepness of the pilot hole.Furthermore in the related risk management file these possible root causes were stated: wrong pilot hole - screw interface due to wrong hole diameter/ tapped hole; insufficient/too high bone quality; wrong/ missing information; improper implant placement; too much/ wrong forces between blade, screw and bone (e.G.Screw head deformation, screw breakage); power tool usage for screw insertion (except qdm); too much/ wrong compression/ torsional/ axial forces; wrong rotational speed, unintended loads; bone quality resulting in high torque; predrilled hole not deep enough (e.G.Wrong choice of instrument/implant, system mix-up, poorly assembled/used instrument); powered screw insertion with right angled screwdriver.No indications were found for any design, material or manufacturing related issue.Therefore, no preventive and/or corrective actions are deemed necessary at this time.

Event Description

It was reported by a company representative that during a mandible angle fracture procedure the screw head broke off from the screw body during torque/insertion.The head part of the screw that broke off was recovered, and the remaining part of the screw body was left in the patient bone.There was no medical intervention reported, and the procedure was completed without a delay.

• Brand Name: LOCKING SCREWS, CROSS-PIN, DIAM.2.0X8MM, (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: gregory gohl ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5926622
• MDR Text Key: 54527833
• Report Number: 0008010177-2016-00212
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

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: 50-20508
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: 08/12/2016
• Supplement Dates FDA Received: 07/14/2017
• 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