MAUDE Adverse Event Report: NORMED MEDIZIN-TECHNIK GMBH EASY EXPLANT SIL SCR T-HND 3,4 MM; EASY EXPLANT T-HANDLE

Catalog Number 507000160

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

The manufacturer did not receive devices or other source documents for review.Compatibility check: the compatibility check was performed and showed that the product combination was approved.Event description: laser marking is not legible.As the instrument has not been returned, a product analysis could not be performed.Therefore, the complaint could not be confirmed for this product.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: EASY EXPLANT SIL SCR T-HND 3,4 MM
• Type of Device: EASY EXPLANT T-HANDLE
• 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: 4951685
• MDR Text Key: 6033361
• Report Number: 9613350-2015-00843
• Device Sequence Number: 1
• Product Code: LXH
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 507000160
• Device Lot Number: 185A15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2015
• Initial Date FDA Received: 07/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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