MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS GLENS 2 PRONG INS/IMP; INSTRUMENT / EXTREMITIES

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Osteopenia/ Osteoporosis (2651); Foreign Body In Patient (2687)

Event Date 05/16/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Product has been received by zimmer biomet and the investigation is in process.

Event Description

It was reported that while during a surgery the screw of the instrument fell into the patient and was retained by the patient.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified item# 405900, lot# 383170 etched near the prongs.The inserter shows minimal signs of use.The retaining pin is missing from the device and was not returned for evaluation.The weldment for the pin appears to be fractured.There is a small crack at the base of the black plastic pad.No other damage noted.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the right shoulder reverse type arthroplasty.Single extra-osseous surgical screw as noted.A definitive 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

No further event information available at the time of this report.

• Brand Name: COMP RVS GLENS 2 PRONG INS/IMP
• Type of Device: INSTRUMENT / EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14684632
• MDR Text Key: 293924310
• Report Number: 0001825034-2022-01394
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 00880304510043
• UDI-Public: (01)00880304510043(10)383170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 405900
• Device Lot Number: 383170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male