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
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2022-00159.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.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: foreign - 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.
Additional 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.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 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.

• Brand Name: CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 30 MM LENGTH
• Common Device Name: 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: 14982630
• Report Number: 0002648920-2022-00160
• Device Sequence Number: 5098524
• Product Code: HRS
• UDI-Device Identifier: 00889024051751
• UDI-Public: (01)00889024051751(11)190611(10)64434785
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 07/11/2022; 07/28/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 07/13/2022; 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10
• Patient Age: 42 YR
• Patient Sex: Male