MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X30 SELF-TAP; PROSTHETIC, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item number: 31-323220, item name: 3.2mmx20mm rnglc+ acet drl bit, lot number: 224580, item number: 110010247, item name: g7 osseoti 4 hole shell 58mm g, lot number: 65446037, item number: 30104007, item name: g7 vit e neutral lnr 40mm g, lot number: 65502242.The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported 6.5 x30 self-tapping acetabular screw split and broke apart while being inserted into a g7 acetabular shell.The screw head split at the 3.5 mm aperture after progressing into the shell about 2cm.The broken screw was retrieved however the screw shank remains in the acetabular shell.Surgeon attempted to remove it and abandoned the effort when it would not easily back out.There was no additional information available at the time of this report.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 d4: expiration and udi g3 g6 h2 h3 h4 h6 h10 visual examination of the returned product identified z etch is present on the head fragment returned.Bio debris was present on the screw head.Galling mark was noted around the outer diameter area of the head fragment.Portion of the hex present show signs of use.Fracture on three sides noted.No other damage noted.The returned screw portion was sent to sem.Results: sem analysis of the bone screw sample.Showed that its head fractured due to torsional overload.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.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.

• Brand Name: BONE SCR 6.5X30 SELF-TAP
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15933942
• MDR Text Key: 305004759
• Report Number: 0001822565-2022-03409
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024119826
• UDI-Public: (01)00889024119826(17)320930(10)J7358560
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006530
• Device Lot Number: J7358560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 FOR ALL PRODUCT INFO
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male