MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.7MM CALIB DRILL BIT; BIT, DRILL

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 110017533, 2.7mm soft tissue drill guide, 3445a.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03651.

Event Description

It was reported that a drill bit cold-welded to the drill guide during drilling.No harm to patient.No delay in surgery.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Concomitant medical products: 110017533, 2.7mm soft tissue drill guide, 3445a, 110017537, 3.2mm calibrated drill bit, unknown, kw20ss, s3 k-wire 2.0x152mm (6 in) ns, unknown, kw20ss, s3 k-wire 2.0x152mm (6 in) ns, unknown, kw20ss, s3 k-wire 2.0x152mm (6 in) ns, unknown, 110030300, prx hum hi plt lt 3h 80mm, unknown, 110017728, screw t15 lp cort 3.5x28mm ns, unknown, 110025330, 3.2mm pegs 30mm, unknown, 110025330, 3.2mm pegs 30mm, unknown, 110025328, 3.2mm pegs 28mm, unknown, 110025328, 3.2mm pegs 28mm, unknown, 110025326, 3.2mm pegs 26mm, unknown, 110025340, 3.2mm pegs 40mm, unknown, 110025340, 3.2mm pegs 40mm, unknown, 110025344, 3.2mm pegs 44mm, unknown, 110025344, 3.2mm pegs 44mm, unknown, 110025334, 3.2mm pegs 34mm, unknown, 110025334, 3.2mm pegs 34mm, unknown, 816135022, 3.5mm cort lock scr 22mm ns, unknown, 816135022, 3.5mm cort lock scr 22mm ns, unknown, 110017724, screw t15 lp cort 3.5x24mm ns, unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The reported drill bit is stuck in the reported guide.The outer diameter of the guide was found to conform to specifications but it was not possible to measure the internal diameter of the guide, due to the presence of the drill bit.Dhr was reviewed and no discrepancies were found.The device is believed to have been conforming to print when it left zimmer biomet control.Based on available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 2.7MM CALIB DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7548246
• MDR Text Key: 109358380
• Report Number: 0001825034-2018-03650
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 214227070
• Device Lot Number: ZB170803
• Other Device ID Number: (01) 00887868024955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1