MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 30 MM LENGTH; PLATE, FIXATION, BONE

Catalog Number 00234702030

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 05/23/2022

Event Type  malfunction  

Event Description

It was reported that patient underwent removal of implanted plates approximately one (1) year after implantation due to successful bone healing.Before removal, x-rays noticed two screws had fractured.Subsequently, doctor decided to keep fractured screws implanted to prevent disturbance to healed bone.Patient was not experiencing any harm or adverse effects as a result of the fractured screws.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2022-00160.Product id was provided for 7 screws, however it is unknown which 2 of the 7 screws reported had fractured.Therefore, the fractured screws could also have the part and lot combination of: item# 00234702026; lot# 64487378.Implant date: exact implant date is unknown.Implant date is approximately one (1) year prior to event date.Concomitant medical products: item# 00234702030; lot# 64434785.Item# 00234702026; lot#64487378.Item# 00234702026; lot#64487378.Item# 00234702026; lot#64487378.Item# 00234702026; lot#64487378.Item# 00234702026; lot#64487378.Item# 00492700803; lot# 64723011.Item# 00492700803; lot# 64723011.(b)(6).Report source: event occurred in china.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.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 Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b3; b4; b5; d6a; g3; g6; h1; h2.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 1.Dorsal plate and screw fixation of the midfoot with interval removal.Loosened screws proximally along the plate.2.Poor quality imaging significantly limits evaluation.Osteopenia also present.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.It is unknown whether the incompatibility caused the reported event; therefore 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.

Event Description

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

• Brand Name: CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 30 MM LENGTH
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14982623
• MDR Text Key: 296056144
• Report Number: 0002648920-2022-00159
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024051751
• UDI-Public: (01)00889024051751(11)190611(10)64434785
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00234702030
• Device Lot Number: 64434785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Age: 42 YR
• Patient Sex: Male