MAUDE Adverse Event Report: NORMED MEDIZIN-TECHNIK GMBH EASY EXPLANT BIT 7 - 3.5MM SS W/SZR PIN

Catalog Number 507001009

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 07/15/2015

Event Type  Other  

Event Description

It is reported that at hospital, upon receipt of original packed instrument, it was detected that the laser marking of the device is illegible.

Manufacturer Narrative

The mfr did not receive devices for review.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Manufacturer Narrative

Trend analysis: a trend was identified.A trend investigation has been initiated.Review of incoming information: laser marking is not readable on every device.No pictures were available.Devices analysis: all devices have a laser marking on the shaft.Item and lot number is marked on the shaft.On the top/head of the bit, the size and the system of the bit is marked.The surface of the device on the top/head is rough.Therefore, the laser marking was not ideally placed on the top/head.Possible causes for the reported event according to dfmea: laser marking not legible on the top/head of the device due to inadequate design for intended handling performance.Possible as the performed investigation showed that the surface of the device on the top/head was rough.Therefore, the laser marking was not ideally placed on the top/head.Based on the given information and the results of the investigation, we could identify a root cause for this issue.The surface of the device on the top/head is rough.Therefore, the laser marking was not ideally placed on the top/head.A capa was initiated to eliminate the root cause.Zimmer's reference number of this file is (b)(4).

• Brand Name: EASY EXPLANT BIT 7 - 3.5MM SS W/SZR PIN
• Type of Device: EASY EXPLANT BIT
• Manufacturer (Section D): NORMED MEDIZIN-TECHNIK GMBH; ulrichstrasse 7; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676
• MDR Report Key: 4951696
• MDR Text Key: 15243920
• Report Number: 9613350-2015-00857
• Device Sequence Number: 1
• Product Code: HTW
• 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,Health Professional,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 507001009
• Device Lot Number: 15917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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