MAUDE Adverse Event Report: ZIMMER BIOMET, INC. QUICK CONNECT GUIDE HANDLE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	110004319
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guide handle broke during a surgery.According to or nurse, the handle is complete but cannot be used.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Foreign: event occurred in (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.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 or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Cosmetic inspection confirms the product has disassembled.The plunger is no longer welded to the body.Cosmetic inspection also found nicks, scratches and worn etching.The fracture site and type is consistent with access quick-connect guide handle plunger fracture complaint summary.Investigation in which overload type of failure was identified.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: QUICK CONNECT GUIDE HANDLE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 12918848
• Report Number: 0001825034-2021-03243
• Device Sequence Number: 5143279
• Product Code: MBF
• UDI-Device Identifier: 00887868462979
• UDI-Public: (01)00887868462979(11)170202(10)900620
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 110004319
• Device Lot Number: 900620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose