MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREWS, SELF DRILLING, 2.0X8MM, 5/P; IMPLANT

Catalog Number 50-20598

Device Problems Break (1069); Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

Event Description

It was reported to the company representative by the surgeon that last friday during a case, the last 1-2mm of a hybrid mmf screw broke off during insertion.It is believed that the tip that broke remains in the patient.The surgeon was not performing the insertion - his residents were applying the hmmf.The screw felt loose, it was backed out, and that's when they noticed the piece missing.The were no adverse consequences nor delay.The broken screw was discarded.

• Brand Name: LOCKING SCREWS, SELF DRILLING, 2.0X8MM, 5/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: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6694465
• MDR Text Key: 79591207
• Report Number: 0008010177-2017-00162
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122313
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-20598
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2017
• 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