MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE HUMERAL CUTTING GUIDE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Mechanical Jam (2983)

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

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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: 0001822565-2019-00280.

Event Description

It was reported that during a shoulder arthroplasty, the pin cold-welded into humeral cut guide.No impact to the surgery or patient was noted.No additional information is available from the event.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned sample shows a pin was seized in the guide.There are heavy wear marks on the humeral cutting guide.Hardness value taken on tm reverse humeral cut template was found to be within specifications.Device history records were reviewed with no deviations/ anomalies identified.A definite root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information is available to report at this time.

• Brand Name: TM REVERSE HUMERAL CUTTING GUIDE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8304368
• MDR Text Key: 134979885
• Report Number: 0001822565-2019-00279
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00430902000
• Device Lot Number: 62209429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN PIN; UNKNOWN PIN