MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MMF SCREWS, 2.0X8MM, CROSS-PIN, SELF DRILLING, 4/P; IMPLANT

Catalog Number 50-20358

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 08/11/2016

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

A company representative reported that a surgeon was using imf ((b)(4)) to restore occlusion and assist in the reduction of a mandible fracture, after pre-drilling the hole.The screw head dislodged/fractured from the self drilling body of the piece (unknown drill part # or drill depth).The company representative was able to get the surgeon to remove screw body from patient.There was not a surgical delay.

Manufacturer Narrative

The product was returned for investigation and the reported event could be confirmed.The investigation shows that the mmf screw, cross-pin, 2.0xxmm, self-drilling broke as a result of too high torsional forces in forced rupture mode during the insertion.The chemical composition conforms to the specification ¿ 1.4441.The fracture surface shows the typical flow structures of a ductile torsional breakage.The root cause of the failure could have been a too hard bone.It is stated that the surgeon pre-drilled the hole against the suggestions from the sales rep.According to the ifu pre-drilling for a mmf-screw is optionally possible.Therefore no product problem is expected.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.- implant/instrument mix-up.- 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.Indications for material or manufacturing related problems were not found in this investigation.Therefore no corrective and/or preventive actions are deemed necessary at that time.

Event Description

A company representative reported that a surgeon was using imf (5020358) to restore occlusion and assist in the reduction of a mandible fracture, after pre-drilling the hole.The screw head dislodged/fractured from the self drilling body of the piece (unknown drill part # or drill depth).The company representative was able to get the surgeon to remove screw body from patient.There was not a surgical delay.

• Brand Name: MMF SCREWS, 2.0X8MM, CROSS-PIN, SELF DRILLING, 4/P
• 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: jonathan schell ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5915719
• MDR Text Key: 54274823
• Report Number: 0008010177-2016-00206
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050535
• 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: 08/12/2016

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: No Information
• Device Catalogue Number: 50-20358
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/28/2016
• 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