MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALPS MIS DRILL GUIDE LK 2.7MM; PLATE, FIXATION

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) concomitant medical products: 214227160, 2.7 x 160 mm calibrated drill ste, unknown.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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- 00367.

Event Description

It was reported that during the procedure the drill was stuck with the guide, and the guide could not move in any direction.The surgeon used another drill and guide to complete the procedure.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: 214227160, 2.7x160mm calibrated drill ste, unknown.110016966, mis calc plt sm extd 2h lt ste, 330460.851235034, 3.5x34mm low pro cort scr ste, 479430.856135022, 3.5x22mm cort lock scr ste, 217990.856135024, 3.5x24mm cort lock scr ste, 452740.856135024, 3.5x24mm cort lock scr ste, 537930.856135028, 3.5x28mm cort lock scr ste, 262360.856135028, 3.5x28mm cort lock scr ste, 473700.856135030, 3.5x30mm cort lock scr ste, 109350.856135034, 3.5x34mm cort lock scr ste, 929730.856135034, 3.5x34mm cort lock scr ste, 929800.

• Brand Name: ALPS MIS DRILL GUIDE LK 2.7MM
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7206858
• MDR Text Key: 98094053
• Report Number: 0001825034-2018-00284
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK132898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• 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: 110008317
• Device Lot Number: 210790
• Other Device ID Number: (01) 00887868076671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Date Manufacturer Received: 02/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1