MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS 3.0 / 4.0 SMOOTH K-WIRE; CAPTURE INSTRUMENTS

Catalog Number AW1103

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to sus voluntary event report (foi for manufacturers) number: mw5075041.

Event Description

It was reported that on (b)(6) 2018, a aw1103 smooth k-wire was used in a procedure.However, the tip broke off about 2 mm in the patient's bone.No patient injury reported.

Manufacturer Narrative

The reported device was not received for evaluation.The device history records (dhr) were reviewed, with no indication of problems in fabrication that could have caused or contributed to the complaint.As the instrument was not returned for examination, no definitive root cause could be determined.

• Brand Name: 3.0 / 4.0 SMOOTH K-WIRE
• Type of Device: CAPTURE INSTRUMENTS
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7341659
• MDR Text Key: 103016681
• Report Number: 1651501-2018-00021
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

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: AW1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1