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

Catalog Number 50-20362

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.The user facility has declined to return the screw head for an investigation.

Event Description

It was reported by the company representative that the mmf grasping sleeve on a ratcheting screwdriver was being used during a case.The screw broke in the maxilla.The surgeon burred away skin in an attempt to remove it but ended up leaving it in after attempting to make it flush with the gingiva.The sales rep does not know the lot number of the screw.The procedure was completed successfully.There was no surgical delay and no medical intervention.

• 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: hans geiger ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5832978
• MDR Text Key: 51873761
• Report Number: 0008010177-2016-00160
• 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
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-20362
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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