MAUDE Adverse Event Report: ZIMMER, INC. INTRAMEDULLARY NAIL EXTRACTION STEINMANN PIN; TRAUMA INSTRUMENT

Catalog Number 00040902100

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).The following sections could not be completed with the limited information provided.

Event Description

It is reported that when the packaging was opened for the pin, it was noticed to be bent prior to use.Another device was used for surgery.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable.The event did not lead to a serious injury, and is not likely to lead to a serious injury if it were to reoccur.The initial report was sent in error and should be voided.

• Brand Name: INTRAMEDULLARY NAIL EXTRACTION STEINMANN PIN
• Type of Device: TRAUMA INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6264951
• MDR Text Key: 65573032
• Report Number: 0001822565-2017-00240
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK143618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 00040902100
• Device Lot Number: 63248526
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2016
• 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