MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE); IMPLANT

Catalog Number 50-20414

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

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation as it was discarded by the facility at their location.If additional information is received it will be reported in a supplemental report.The product was discarded by the facility at their location.

Event Description

It was reported that during a mandible fracture procedure the head of a screw broke off from the screw body during torque/insertion.The shaft part of the screw that broke off was left in the patient.No medical intervention was reported with this event.The procedure was completed successfully without a delay.

• Brand Name: BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (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: 7439871
• MDR Text Key: 106260972
• Report Number: 0008010177-2018-00034
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-20414
• Device Lot Number: UNKNOWN, STOCKED SET
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• 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