MAUDE Adverse Event Report: NORMED MEDIZIN-TECHNIK GMBH SUBTALAR CBS SYS 7.5 C SINK CANN AO 80MM; BURR, ORTHOPEDIC

Catalog Number 503004350

Device Problem Corroded (1131)

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

Event Date 11/12/2014

Event Type  Injury  

Event Description

It was reported that during the kit inspection rust was detected on a subtalar cbs sys 7.5 sink cann ao 80mm on (b)(6) 2014 after return of the hospitals.It was also reported that there was already a black shine on the instruments at the operation.

Manufacturer Narrative

The mfr received the device for investigation on november 20 2014.The investigation is pending.Pictures of the device were received for review.As the lot number of the instrument is unreadable due to rust, it is not possible to check the dhr at the moment.A cause for this specific event cannot be ascertained from the info provided.Should additional info become available and an investigation result be available that changes this assessment, an amended med device report will be submitted.(b)(4).

• Brand Name: SUBTALAR CBS SYS 7.5 C SINK CANN AO 80MM
• Type of Device: BURR, ORTHOPEDIC
• Manufacturer (Section D): NORMED MEDIZIN-TECHNIK GMBH; ulrichstrasse 7; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581--070 ; 5742676
• MDR Report Key: 4308607
• MDR Text Key: 5131527
• Report Number: 9613350-2014-04162
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2014

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
• Device Catalogue Number: 503004350
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: No
• 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