MAUDE Adverse Event Report: NORMED MEDIZIN-TECHNIK GMBH NORMED GEMERIC TRAUMA; UNKNOWN

Device Problem Corroded (1131)

Patient Problem No Information (3190)

Event Date 01/22/2014

Event Type  Other  

Event Description

It was reported that an easy explant bit (drill bit) showed corrosion.As the occurrence date of the event is unk, the mfr's awareness date was taken as occurrence date.

Manufacturer Narrative

The mfr did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the info provided.Once more detailed info becomes available, a follow-up report will be filed.(b)(4).

• Brand Name: NORMED GEMERIC TRAUMA
• Type of Device: UNKNOWN
• Manufacturer (Section D): NORMED MEDIZIN-TECHNIK GMBH; ulrichstrasse 7; tuttlingen ; SZ
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 5742676
• MDR Report Key: 4290386
• MDR Text Key: 5081066
• Report Number: 9613350-2014-04135
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 11/24/2014
• 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
• Patient Outcome(s): Other