MAUDE Adverse Event Report: NORMED MEDIZIN-TECHNIK GMBH TARSALIS TI PLT 14-HS STR

Catalog Number 28.07.380

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 03/10/2015

Event Type  Other  

Event Description

It was reported that the pt was implanted a tarsalis ti plate 14-hs str, on an unk date, to heal an ulna fracture.Shortly after implantation the plate broke even though the arm of the pt was under the plaster cast.Nb: the tarsalis system was developed for internal fixation of the midfoot, in this case the tarsalis plate was implanted to heal an ulna fracture.

Manufacturer Narrative

Please be aware that the tarsalis system was developed for internal fixation of the midfoot, in this case the tarsalis plate was implanted to heal an ulna fracture.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.Should additional info become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

• Brand Name: TARSALIS TI PLT 14-HS STR
• Type of Device: TARSALIS TI PLT
• Manufacturer (Section D): NORMED MEDIZIN-TECHNIK GMBH; ulrichstrasse 7; tuttlingen ; GM
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676
• MDR Report Key: 4648082
• MDR Text Key: 5596213
• Report Number: 9613350-2015-00367
• Device Sequence Number: 1
• Product Code: HRS
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2015

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: Lay User/Patient
• Device Catalogue Number: 28.07.380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other