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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, SCREW, 5.0, 36 MM NCB PLATING SYSTEM

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ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, SCREW, 5.0, 36 MM NCB PLATING SYSTEM Back to Search Results
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 02/01/2021
Event Type  Injury  
Manufacturer Narrative

Concmitant medical products: item number: 0203150300, item namencb, locking cap, lot #unknown. Item number 47223206001, item name ncb, cable button for ncb polyaxial locking plate, 2. 5 mm hex drive, lot #unknown. Item number 00223200418, item name cable cerclage cable with crimp 1. 8 mm dia. 635 mm length, lot #unknown. Item number 0200024001, item name ncb, drill bit, 4. 3 mm, 145 mm, lot #unknown. Item number 29020280, item name kirschner wire with trocar tip, 2 mm, 280 mm, lot #unknown. Item number 0203150050, item name ncb, screw, 5. 0, 50 mm, lot #unknown. Item number 0203150080, item name ncb, screw, 5. 0, 80 mm, lot #unknown. Review of event description: it was reported that the patient received an implant on (b)(6) 2020 and was revised on (b)(6) 2021 due to implant fracture (2 screws) and wear between the two distal screws and the ncb plate, leading to a migration of the ncb plate. 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: several x-ray images are provided for review. The review was done by a radiologist. Image demonstrates lateral side plate and screw fixation with cement noted at the proximal femoral diaphysis. Peri-implant fracture image demonstrates similar hardware with possible curvilinear lucency along the base of the femoral neck. Image labeled revision to reversed ncb-df demonstrates revision surgery with lateral side plate and screw fixation with multiple screws and cerclage wire. Removal of cement of the proximal femoral diaphysis with possible fracture in this region. Images labeled current incident ((b)(6) 2021) demonstrate fractured proximal hardware with loosening of the femoral plate and fracture of the third distal most screw. The plate has separated from the screws and the bone on these images. Product evaluation: visual examination: the ncb plate and some ncb screws were returned for investigation. The visual examination of the plate shows some wear on the first and second screw holes distally and can be seen from the bone facing side of the plate. Compared to the other screw holes the facets of these two bore holes are worn and not visible anymore. These are the screw holes where the two screws heads were pulled through. Two of the delivered screws show circumferential wear and possible fretting marks on the screw head. In addition, there are two broken screws available. The fractured parts of the screws were also returned. Some of the screws show some damages on the thread area. No relevant damages or deformations can be seen on the plate and locking caps. 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 for the plate during manufacturing. Conclusion: it was reported that the patient received an implant on (b)(6) 2020 and was revised on (b)(6) 2021 due to implant fracture (2 screws) and wear between the two distal screws and the ncb plate, leading to a migration of the ncb plate. The quality records show that all specified characteristics (material, dimensions, surface, etc. ) for the ncb plate and screws have met the specifications valid at the time of production. Therefore, the investigation results did not identify a non-conformance or a complaint out of box (coob). The delivered x-rays as well as the visual examination confirm the breakage of two screws and the migration of the plate. The x-rays also showed that a distal femur plate was implanted for a fracture in the proximal femur section. The visual examination shows wear on two screw heads and the two most distal screw holes of the plate. The wear on the screw and the plate combined indicates movements between the two components. It can be assumed that these two screws were placed in the two distal screw holes and were the two screws that were pulled through the plate. It was noted that the surgeon did not use locking caps for the most distal two screws. The locking caps are firmly fixed with the screw heads. After using locking caps, a movement of the screws should not be possible. After approx. Seven months of in vivo time without fixation of locking caps and permanent cyclical loading, it is possible that the screws can slightly move. These ongoing small movements can then possibly lead to this phenomenon. Any further contributing factors that might have contributed to the course of events remains unknown. Therefore, based on the available information and performed investigation, an exact root cause for the screw breakages and migration of the plate could not be determined. The need for corrective measures is not indicated and zimmer (b)(4) manufacturing gmbh considers this case as closed. Zimmer biomet's reference number of this file is (b)(4).

 
Event Description

It was reported that the patient was revised on (b)(6) 2021 due to implant fracture (2 screws) and wear between the two distal screws and the ncb plate, leading to a migration of the ncb plate. Note: this product has been added to the affected device during investigation.

 
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Brand NameNCB, SCREW, 5.0, 36 MM
Type of DeviceNCB PLATING SYSTEM
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12307032
MDR Text Key266002685
Report Number0009613350-2021-00399
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeSN
PMA/PMN NumberK042695
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/11/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue Number02.03150.036
Device LOT Number3009577
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/03/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/23/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/29/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/11/2021 Patient Sequence Number: 1
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