MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKONW PIN; SHOULDER, INSTRUMENT

Model Number N/A

Device Problems Separation Failure (2547); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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: 0001822565-2018-03296.

Event Description

It was reported that during a shoulder procedure, the guide pin was stuck in the guide.Another same instrument was used to complete the procedure.No harm to the patient or delay in procedure was noted.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

The follow up report is being submitted to relay additional information the complaint cannot be confirmed as no medical records or pictures were provided.Device history records cannot be reviewed since the lot number is unknown.A definite 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.

Event Description

It was reported that during a shoulder procedure, the guide pin was stuck in the guide.Another same instrument was used to complete the procedure.No harm to the patient or delay in procedure was noted.No additional information is available.

• Brand Name: UNKONW PIN
• Type of Device: SHOULDER, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7609676
• MDR Text Key: 111855024
• Report Number: 0001822565-2018-03297
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• 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: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1