MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TM REVERSE SHOULDER SYSTEM INSTRUMENTATION BASEPLATE CANNULATED REAMER 2; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Product has been returned to zimmer biomet for investigation, but the evaluation has not yet been completed.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a left shoulder arthroplasty, the cannulated reamer was difficult to remove from the surgical site and the reamer drive shaft disengaged from the reamer.Subsequently, the reamer fractured into the patient's wound while it was being retrieved.All fractured pieces were removed.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.As received the reamer was fractured.Hardness and dimensions taken are within specification.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to 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: ZIMMER TM REVERSE SHOULDER SYSTEM INSTRUMENTATION BASEPLATE CANNULATED REAMER 2
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6583393
• MDR Text Key: 75715803
• Report Number: 0001822565-2017-03453
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00430904202
• Device Lot Number: 62452412
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR