MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER CANNULATED DRILL WITH STOP; BIT, DRILL

Device Problem Break (1069)

Patient Problems Pneumothorax (2012); Distress (2329)

Event Date 03/03/2014

Event Type  Injury  

Event Description

From the op note: summary and findings: uncemented zimmer trabecular metal prosthesis, size 36 glenosphere, the smallest concave liner, size 10 humeral stem, 2 screws for the glenoid platform.'the drill bit that was used as a guide for reaming the post-hole for the glenoid platform had broken.A day later it was appreciated that it was the drill bit that had produced the patient's pneumothorax.Since this dictation is a day late, i am able to relate the events that occurred postoperatively.The patient started having distress up on the floor, a couple hours after the operation.She said it started all of sudden; it was obvious when it started.They had transferred her from her gurney to the table and it was clear, all of a sudden, that she was in distress.Up to that point there had not been a problem.A chest x-ray at that time showed the pneumothorax.I was able to examine the chest x-ray.It did not appear that the drill bit was in contact with the thorax.I was aware that the drill bit had broken during the course of the operation.Ultimately i think what happened was the drill bit was inserted to an appropriate depth.We had difficulty with exposure, a little bit more than usual, thus i placed the 6 mm reamer over the drill.The cannulated reamer became bound to the drill, however.I think what happened was the binding of the cannulated reamer over the drill, advanced the drill further, and that is what penetrated the rib.I do not think the drill, just being pushed, could have penetrated the rib.I think it had to be drilled, and so the drill bit was advanced and went through the rib with the reaming.As the reamer was removed, the drill broke at some point in that phase.The drill bit was not visible in the hole created.It was visible on the x-rays, we were concerned with exposure and the intimate details of relocating the shoulder and such, because it was so tight.The screws were well in place and the platform was well seated.It was when the patient got to the floor that it dislodged the drill bit from the rib and produced the pneumothorax.Otherwise, the operation went quite well.It was awfully tight though and difficult to place the components.She was extremely stable at the conclusion of the operation.' the patient returned to surgery the next day, the drill bit segment was removed and the pt recovered without complication.

• Brand Name: ZIMMER CANNULATED DRILL WITH STOP
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER, INC.; 345 east main street; warsaw IN 46580
• MDR Report Key: 3750517
• MDR Text Key: 4485836
• Report Number: 3750517
• Device Sequence Number: 2
• Product Code: HTW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/01/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2014
• Patient Sequence Number: 1
• Treatment: ZIMMER CANNULATED SLEEVE FOR THE DRILL BIT.; OTHER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 61