MAUDE Adverse Event Report: BIOMET UK LTD. G7 HARD BEARING INST RING SZ C ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report. Report source, foreign - event occurred in (b)(6). We have been informed by the customer that the product will not be returned to zimmer biomet for investigation. Associated product: medical product: g7 dual mobility liner 38mm c, catalog #: 110024461, lot #:638880. Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that during impaction the inserter ring broke in two. Attempts have been made and no further information has been provided at this time.

• Brand Name: G7 HARD BEARING INST RING SZ C
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11870171
• MDR Text Key: 252167181
• Report Number: 3002806535-2021-00222
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 110026852
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/09/2021
• 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: Unkown
• Removal/Correction Number: N/A