MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB SCREW, 5.0, 30 MM; NCB PLATING SYSTEM

Model Number N/A

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

Patient Problem Failure of Implant (1924)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

Medical products: cerclage cable with crimp 1.8 mm dia.Cable 22 in.(559 mm) length; catalog#: 00-2232-001-18; lot#: 64816324, ncb, periprosthetic femur plate, proximal, right, 18 holes, 363 mm; catalog#: 02.03263.018; lot#: zbcrza1911, ncb, screw, 5.0, 32 mm; catalog#: 02.03150.032; lot#: 3039889.Ncb, screw, 5.0, 36 mm; catalog#: 020.3150.036; lot#: 3042146.Ncb, screw, 5.0, 38 mm; catalog#: 02.03150.038; lot#: 3033792.Ncb, screw, 5.0, 42 mm; catalog#: 02.03150.042; lot#: zbcrza1911.Ncb, screw, 5.0, 48 mm; catalog#: 02.03150.048; lot#: zbcrza1911.Cerclage cable with crimp 1.8 mm dia.Cable 22 in.(559 mm) length; catalog#: 00-2232-001-18; lot#: 64797017.Ncb, cable button for ncb polyaxial locking plate, 2.5 mm hex drive; catalog#: 47-2232-060-01; lot#: 3035077.Kirschner wire with trocar tip, 2 mm, 280 mm; catalog#: 29020280; lot#: 4503795182.Ncb, locking cap; catalog#: 02.03150.300; lot#: 4503824193.Unicortical screw 5.0 mm diameter 14 mm length warning: this device is not approved for screw attachment or fixation; catalog#: 02.03151.014; lot#: zbcrza1911.Drill bit with quick coupling, 2-fluted, 2.5 mm, 154/180 mm; catalog#: 10325180; lot#: 4503769485.Therapy date: (b)(6) 2020.The manufacturer did receive x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and underwent revision due to fracture and loosening.

Event Description

Patient was implanted on the right side and underwent a revision surgery due to fracture and loosening.

Manufacturer Narrative

Additional information was received on apr 30, 2021.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).

Manufacturer Narrative

Investigation results were made available.1.Event description: it was reported by the patient that the plate was implanted on (b)(6) 2020.A revision surgery was done on (b)(6) 2020 due to a broken screw and cerclage wire.Harm: s3 - instability, moderate hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: some x-ray pictures were received.The pictures show a broken screw head.It can also be seen that a cerclage wire is ruptured.Images: a picture of the explanted products is available.The plate, screws and wires were explanted.The broken screw and cerclage wire can be seen.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.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.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.5.Conclusion: it was reported by the patient that the plate was implanted on (b)(6) 2020.A revision surgery was done on (b)(6) 2020 due to a broken screw and cerclage wire.No product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the parts is unknown.Based on the provided x-rays and picture of explanted devices, the reported event can be confirmed.The investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation results are now available.

• Brand Name: NCB SCREW, 5.0, 30 MM
• Type of Device: NCB PLATING SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11560984
• MDR Text Key: 241991613
• Report Number: 0009613350-2021-00136
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024295711
• UDI-Public: 00889024295711
• Combination Product (y/n): N
• PMA/PMN Number: K042695
• 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: 07/09/2021

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: 02.03150.030
• Device Lot Number: 3015034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 04/30/2021; 07/02/2021
• Supplement Dates FDA Received: 05/11/2021; 07/09/2021
• 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 Weight: 72