MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SCREWDRIVER BALDE FOR 2.0/2.3MM MP SCREWS; EXEMPT

Catalog Number 60-20140

Device Problems Disconnection (1171); Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

During surgery, the screwdriver blade was not long enough to tighten the screws fully.The surgeon struggled and eventually the screwdriver handle disengaged when it came up against the patient's cheek.Surgeon managed to tighten screws.

Manufacturer Narrative

Device not returned for evaluation as it was discarded by the hospital.If additional information is received it will be reported on a supplemental report.

• Brand Name: SCREWDRIVER BALDE FOR 2.0/2.3MM MP SCREWS
• Type of Device: EXEMPT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer Contact: jamshed badarpura ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 3773503
• MDR Text Key: 15124233
• Report Number: 0008010177-2014-00112
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/01/2014

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: Health Professional
• Device Catalogue Number: 60-20140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1