MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MMF SCREWS,2.0X12MM, CROSS-PIN, SELF DRILLING, 4/P; IMPLANT

Catalog Number 50-20362

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 12/26/2016

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 during an orif mandible fracture, part # 5020362 (12mm mmf) fractured at around the 5th thread.The attending physician stated that the snap happened when they were trying to back the screw out.The screw head was salvaged and cleaned for return to stryker.The remaining part of the screw broke off within the inner cortex of the mandible without any piece protruding.An in-op x-ray showed it was too close to the tooth root to attempt removal.

Manufacturer Narrative

The product was returned for investigation and the reported event could be confirmed.The investigation results show that the mmf screw, cross-pin, 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.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 during an orif mandible fracture, part # 5020362 (12 mm mmf) fractured at around the 5th thread.The attending physician stated that the snap happened when they were trying to back the screw out.The screw head was salvaged and cleaned for return to stryker.The remaining part of the screw broke off within the inner cortex of the mandible without any piece protruding.An in-op x-ray showed it was too close to the tooth root to attempt removal.

• Brand Name: MMF SCREWS,2.0X12MM, 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: 6227222
• MDR Text Key: 64338225
• Report Number: 0008010177-2017-00005
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 50-20362
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2016
• 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