MAUDE Adverse Event Report: ZIMMER GMBH SCREW FOR SCREW PLATES, 110 MM + COMPRESSION SCREW

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: hip screw plate; catalog#: 25130004r; lot#: unknown.Corticle screw; catalog#: unknown; lot#: unknown.Therapy date: (b)(6) 2019.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

Patient was implanted on an unknown side and underwent revision surgery due to malunion.3 screws were used.

Manufacturer Narrative

Additional information which was received on sep 15, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and underwent revision surgery due to malunion.3 screws were used.

Manufacturer Narrative

Investigation results were made available.Event description: a retrospective study to collect data on the dhs reported a malunion in a patient (id: (b)(6)) certainly due to device and/or study procedure.The dhs was removed and changed to a thr on (b)(6) 2019.Review of received data: x-rays: no x-rays provided due to privacy policy.Surgical report: no medical reports such as surgical reports or office visit notes provided due to patient privacy policy.Patient data: female, 82 years of age at time of event, 66 kg, 165 cm, bmi: 24,2.Product evaluation: the devices were discarded; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: a retrospective study to collect data on the dhs reported a malunion in a patient (id: 96) certainly due to device and/or study procedure.The dhs was removed and changed to a thr on (b)(6) 2019.Neither x-rays, operative notes, office visit notes, nor device(s) or photos of the device(s) were received; therefore, the condition of the component(s) is unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity, relevant medical history and adherence to rehabilitation protocol are unknown.Solely, based on the description the reported event cannot be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a non-conformance or a complaint out of box (coob).Based on the given information and the results of the investigation, it is possible that patient and procedure related factors led or contributed to the malunion leading to revision.Nevertheless, based on the unavailability of the devices and due to significant lack of medical records a specific root cause could not be identified.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2020-00151-2, 0009613350-2020-00132-1.

Event Description

Investigation has been completed.

• Brand Name: SCREW FOR SCREW PLATES, 110 MM + COMPRESSION SCREW
• Type of Device: SCREW FOR SCREW PLATES
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9882080
• MDR Text Key: 186694906
• Report Number: 0009613350-2020-00152
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2020

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: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 25050110R
• Device Lot Number: 2837991
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 09/15/2020; 09/23/2020
• Supplement Dates FDA Received: 09/24/2020; 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 66