MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONF INTRO NDLE, DIA, 11G 6"; CEMENT / CEMENT ACCESSORY

Catalog Number 283903611

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Sample not returned for evaluation.

Event Description

The surgeon was using the confidence needle 11 x 6g, to locate the tear drop for iliac screw placement.Prior to using this, we had used 2 pieces for the needles, which bent.Upon locating the right placement, the inner trocher was removed, and a viper guide wire was placed in.While removing the wire the surgeon faced some resistance.Upon removing the needle, we found out that part of the needle had broken.We had taken i/i image to confirm this, and the broken part measuring about 5cm looks embedded to the bone.The surgeon tried to remove the broken part but failed.Decision was made to leave it.

• Brand Name: CONF INTRO NDLE, DIA, 11G 6"
• Type of Device: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5297934
• MDR Text Key: 33517328
• Report Number: 1526439-2015-11065
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: PEXEMPT
• 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: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 283903611
• Device Lot Number: HTHBJ5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/18/2015
• 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