MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SCREWDRIVER HANDLE, REVOLVING/RIGID, MANDIBULAR FRACTURE AND RECONSTRUCTION SYST; INSTRUMENT

Catalog Number 62-20295

Device Problem Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 03/31/2014

Event Type  malfunction  

Event Description

During surgery, the pin dropped out of the driver handle to the patient oral cavity.After that the pin was removed from the patient oral cavity.

Manufacturer Narrative

Investigation in progress but not yet complete.

Manufacturer Narrative

The reported event that one fixing screw of the handle dropped out could be confirmed.The visual examination of the screwdriver handle showed that on one side of the handle front part the fixing screw is detached.The detached fixing screw was recovered and returned.On the other side of the handle front part the second fixing screw is firmly attached.Depart from that the function of the revolving/rigid mechanism and blade release was not affected.The microscopic investigation showed that the countersink of the screw hole and related screw shows typically friction traces.The typically friction traces are a result of the friction between screw and screw hole during tightening and indicates that the fixing screw was initially attached and firmly tightened.A loosening of itself is very implausible.Moreover during assembly of the screwdriver handle a 100% self worker control takes place.Indications for any product related problems were not found in the investigation.

Event Description

During surgery, the pin dropped out of the driver handle to the patient oral cavity.After that the pin was removed from the patient oral cavity.

• Brand Name: SCREWDRIVER HANDLE, REVOLVING/RIGID, MANDIBULAR FRACTURE AND RECONSTRUCTION SYST
• Type of Device: INSTRUMENT
• 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: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 3773511
• MDR Text Key: 4357620
• Report Number: 0008010177-2014-00114
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2014

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: 62-20295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 04/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2006
• 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