MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X25MM ST/RST; ORTHOPEDIC BONE SCREW

Catalog Number 115395

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: comp rvs cntrl 6.5x25mm st/rst cat# 115395 lot# 291830, comp lk scr 3.5hex 4.75x30 st cat# 180553 lot# 131540, comp lk scr 3.5hex 4.75x25 st cat# 180552 lot# 420030, comp lk scr 3.5hex 4.75x15 st cat# 180550 lot# 293940, comp rvrs shldr glnsp std 36mm cat# 115310 lot# 679520, comp primary stem 10mm mini cat# 113630 lot# 64548820, cr prolong 36mm brng std cat# 110031418 lot# 64690210, mini tray std cocr +3 offset cat# 110031402 lot# 64675200.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history records were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified: ncr12795066 the root cause of the reported issue is attributed to a manufacturing deficiency.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

It was reported the surgeon was unsatisfied with the way the plate was impacting, and after some adjusting, decided on a different screw.The original screw was discarded and not implanted.No issues or problems for the surgeon or patient were experienced due to this event.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COMP RVS CNTRL 6.5X25MM ST/RST
• Type of Device: ORTHOPEDIC BONE SCREW
• 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: 11302906
• MDR Text Key: 232537741
• Report Number: 0001825034-2021-00416
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304677074
• UDI-Public: (01)00880304677074(17)301010(10)077170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 115395
• Device Lot Number: 077170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1